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Dear Friends,

Since moving to Missouri a little over 2 years ago, I got involved with the Missouri GI Society. They held their inaugural in-person meeting in September, and it was exciting to see and meet gastroenterologists and associates from all over the state. The meeting sparked conversations about challenges in practices and ways to improve patient care. It was incredibly inspiring to see the beginnings and bright future of a society motivated to mobilize change in the community. On a national scale, AGA Advocacy Day 2025 this fall was another example of how to make an impact for the field. I am grateful that local and national GI communities can be a platform for our voices.

In this issue’s “In Focus,” Dr. Colleen R. Kelly discusses the approach for weight management for the gastroenterologist, including how to discuss lifestyle modifications, anti-obesity medications, endoscopic therapies, and bariatric surgeries. In the “Short Clinical Review,” Dr. Ekta Gupta, Dr. Carol Burke, and Dr. Carole Macaron review available non-invasive blood and stool tests for colorectal cancer screening, including guidelines recommendations and evidence supporting each modality.

In the “Early Career” section, Dr. Mayada Ismail shares her personal journey in making the difficult decision of leaving her first job as an early career gastroenterologist, outlining the challenges and lessons learned along the way.

Dr. Alicia Muratore, Dr. Emily V. Wechsler, and Dr. Eric D. Shah provide a practical guide to tech and device development in the “Finance/Legal” section of this issue, outlining everything from intellectual property ownership to building the right team, and selecting the right incubator.

If you are interested in contributing or have ideas for future TNG topics, please contact me ([email protected]) or Danielle Kiefer ([email protected]), Communications/Managing Editor of TNG.

 

Until next time, I leave you with a historical fun fact because we would not be where we are now without appreciating where we were: screening colonoscopy for colorectal cancer was only first introduced in the mid-1990s with Medicare coverage for high-risk individuals starting in 1998, followed by coverage for average-risk patients in 2001.

Yours truly, 

Judy A. Trieu, MD, MPH

Editor-in-Chief

Assistant Professor of Medicine

Interventional Endoscopy, Division of Gastroenterology

Washington University School of Medicine in St. Louis

Dear Friends,

Since moving to Missouri a little over 2 years ago, I got involved with the Missouri GI Society. They held their inaugural in-person meeting in September, and it was exciting to see and meet gastroenterologists and associates from all over the state. The meeting sparked conversations about challenges in practices and ways to improve patient care. It was incredibly inspiring to see the beginnings and bright future of a society motivated to mobilize change in the community. On a national scale, AGA Advocacy Day 2025 this fall was another example of how to make an impact for the field. I am grateful that local and national GI communities can be a platform for our voices.

In this issue’s “In Focus,” Dr. Colleen R. Kelly discusses the approach for weight management for the gastroenterologist, including how to discuss lifestyle modifications, anti-obesity medications, endoscopic therapies, and bariatric surgeries. In the “Short Clinical Review,” Dr. Ekta Gupta, Dr. Carol Burke, and Dr. Carole Macaron review available non-invasive blood and stool tests for colorectal cancer screening, including guidelines recommendations and evidence supporting each modality.

In the “Early Career” section, Dr. Mayada Ismail shares her personal journey in making the difficult decision of leaving her first job as an early career gastroenterologist, outlining the challenges and lessons learned along the way.

Dr. Alicia Muratore, Dr. Emily V. Wechsler, and Dr. Eric D. Shah provide a practical guide to tech and device development in the “Finance/Legal” section of this issue, outlining everything from intellectual property ownership to building the right team, and selecting the right incubator.

If you are interested in contributing or have ideas for future TNG topics, please contact me ([email protected]) or Danielle Kiefer ([email protected]), Communications/Managing Editor of TNG.

 

Until next time, I leave you with a historical fun fact because we would not be where we are now without appreciating where we were: screening colonoscopy for colorectal cancer was only first introduced in the mid-1990s with Medicare coverage for high-risk individuals starting in 1998, followed by coverage for average-risk patients in 2001.

Yours truly, 

Judy A. Trieu, MD, MPH

Editor-in-Chief

Assistant Professor of Medicine

Interventional Endoscopy, Division of Gastroenterology

Washington University School of Medicine in St. Louis

Dear Friends,

Since moving to Missouri a little over 2 years ago, I got involved with the Missouri GI Society. They held their inaugural in-person meeting in September, and it was exciting to see and meet gastroenterologists and associates from all over the state. The meeting sparked conversations about challenges in practices and ways to improve patient care. It was incredibly inspiring to see the beginnings and bright future of a society motivated to mobilize change in the community. On a national scale, AGA Advocacy Day 2025 this fall was another example of how to make an impact for the field. I am grateful that local and national GI communities can be a platform for our voices.

In this issue’s “In Focus,” Dr. Colleen R. Kelly discusses the approach for weight management for the gastroenterologist, including how to discuss lifestyle modifications, anti-obesity medications, endoscopic therapies, and bariatric surgeries. In the “Short Clinical Review,” Dr. Ekta Gupta, Dr. Carol Burke, and Dr. Carole Macaron review available non-invasive blood and stool tests for colorectal cancer screening, including guidelines recommendations and evidence supporting each modality.

In the “Early Career” section, Dr. Mayada Ismail shares her personal journey in making the difficult decision of leaving her first job as an early career gastroenterologist, outlining the challenges and lessons learned along the way.

Dr. Alicia Muratore, Dr. Emily V. Wechsler, and Dr. Eric D. Shah provide a practical guide to tech and device development in the “Finance/Legal” section of this issue, outlining everything from intellectual property ownership to building the right team, and selecting the right incubator.

If you are interested in contributing or have ideas for future TNG topics, please contact me ([email protected]) or Danielle Kiefer ([email protected]), Communications/Managing Editor of TNG.

 

Until next time, I leave you with a historical fun fact because we would not be where we are now without appreciating where we were: screening colonoscopy for colorectal cancer was only first introduced in the mid-1990s with Medicare coverage for high-risk individuals starting in 1998, followed by coverage for average-risk patients in 2001.

Yours truly, 

Judy A. Trieu, MD, MPH

Editor-in-Chief

Assistant Professor of Medicine

Interventional Endoscopy, Division of Gastroenterology

Washington University School of Medicine in St. Louis

Introduction

Colorectal cancer (CRC) screening significantly reduces CRC incidence and mortality, but only 65% of eligible individuals report being up-to-date with screening.¹ Colonoscopy is the most widely used opportunistic screening method in the United States and is associated with many barriers to uptake. Providing patients a choice of colonoscopy and/or stool-based tests, improves screening adherence in randomized controlled trials.^2,3 Non-invasive screening options have expanded from stool occult blood and multi-target DNA tests, to multi-target stool RNA tests, and novel blood-based tests, the latter only U.S. Food and Drug Administration (FDA) approved for patients who refuse colonoscopy and stool-based tests. This review summarizes the test characteristics of stool and blood CRC screening options and provides guidance on clinical implications of their use.

Stool Occult Blood Tests

Guaiac-based fecal occult blood testing (gFOBT) significantly reduces CRC mortality by 33%-35% when implemented on an annual or biennial basis.^4,5 Fecal immunochemical testing (FIT) has supplanted gFOBT with advantages including independence from dietary restriction and medication-related interference, use of antibodies specific to human globin, and the need for only a single stool sample.

The most common threshold for a positive FIT in the U.S. is ≥ 20 micrograms (μg) of hemoglobin per gram (g) of stool. FIT is approved by the FDA as a qualitative positive or negative result based on a threshold value.⁶ A meta-analysis summarized test characteristics of commercially available FITs at various detection thresholds.⁷ The CRC sensitivity and specificity was 75% and 95% for ≥ 20 ug hemoglobin/g stool, and 91% and 90% for 10 ug hemoglobin/g stool, respectively. The sensitivity for advanced adenomas ranged from 25% at 20 μg/g to 40% at a 10 μg/g. Programmatic use of FIT in adults ages ≥ 50 years at 20 ug/g of stool, in cohort and case control studies, has been shown to significantly reduce CRC mortality by 33%-40% and advanced stage CRC by 34%.^8,9

Over 57,000 average-risk individuals ages 50–69 years were randomized to biennial FIT or one-time colonoscopy and followed for 10 years.¹⁰ CRC mortality and incidence was similar between the groups: 0.22% with FIT vs. 0.24% with colonoscopy and 1.13% with FIT vs. 1.22% with colonoscopy, respectively. Thus, confirming biennial FIT screening is non-inferior to one-time colonoscopy in important CRC-related outcomes.
 

Multi-Target Stool Tests

Two multitarget stool DNA tests (mt-sDNA) known as Cologuard™ and Cologuard Plus™ have been approved by the FDA. Both tests include a FIT (with a positivity threshold of 20 μg hemoglobin per gram of stool) combined with DNA methylation markers. The test result is qualitative, reported as a positive or negative. Cologuard™ markers include methylated BMP3, NDRG4, and mutant KRAS while Cologuard Plus™ assesses methylated LASS4, LRRC4, and PPP2R5C. The respective mt-sDNA tests were studied in 9989 of 12,776 and 20,176 of 26,758 average-risk individuals undergoing colonoscopy and the results were compared to a commercially available FIT (with a positivity threshold of 20 μg hemoglobin/gram of stool).^11,12 In both trials, the sensitivity for CRC and advanced precancerous lesions was higher with the mt-sDNA tests compared to FIT but had a significantly lower specificity for advanced precancerous lesions versus FIT (see Table 1). An age-related decline in specificity was noted in both trials with mt-sDNA, a trend not observed with FIT. This reduction may be attributed to age-related DNA methylation.

Multi-Target Stool RNA Test

A multi-target stool RNA test (mt-sRNA) commercially available as ColoSense™ is FDA-approved. It combines FIT (at a positivity threshold of 20 μg hemoglobin/gram of stool) with RNA-based stool markers. The combined results of the RNA markers, FIT, and smoking status provide a qualitative single test result. In the trial, 8,920 adults aged ≥45 underwent the mt-sRNA test and FIT followed by colonoscopy (13). The mt-sRNA showed higher sensitivity for CRC than FIT (94.4% versus 77.8%) and advanced adenomas (45.9% versus 28.9%) but lower CRC specificity (84.7% vs 94.7%) (Table 1). Unlike mt-sDNA-based tests, mt-sRNA showed consistent performance across age groups, addressing concerns about age-related declines in specificity attributed to DNA methylation. 
 

Blood-Based Tests

In 2014, the first blood-based (BBT) CRC screening test known as Epi proColon™ was FDA but not Centers for Medicare & Medicaid Services (CMS) approved for average-risk adults ≥50 years of age who are offered and refused other U.S Preventive Services Task Force (USPSTF) endorsed CRC screening tests. It is a qualitative test for detection of circulating methylated Septin 9 (mSeptin9). The accuracy of mSeptin9 to detect CRC was assessed in a subset of 7941 asymptomatic average risk adults undergoing screening colonoscopy.¹⁴ The sensitivity and specificity for CRC were 48% and 91.5%, respectively. The sensitivity for advanced adenomas was 11.2%. An increase in sensitivity to 63.9% and reduction in specificity to 88.4% for CRC was demonstrated in a sub-analysis of available samples where an additional (third) polymerase chain replicate was performed. Epi proColon™ is not currently reimbursed by Medicare and not endorsed in the latest USPSTF guidelines.

Technologic advancements have improved the detection of circulating tumor markers in the blood. The Shield™ BBT approved by the FDA in 2024 for average risk adults ≥ 45 years integrates three types of cfDNA data (epigenetic changes resulting in the aberrant methylation or fragmentation patterns, and genomic changes resulting in somatic mutations) into a positive or negative test result. In the trial, 22,877 average-risk, asymptomatic individuals ages 45–84 were enrolled and clinical validation was performed in 7,861 of the participants.¹⁵ The sensitivity for CRC was 83.1% which decreased to 55% for stage I tumors (see Table 1). CRC specificity was 89.6% and the sensitivity for advanced adenomas and large sessile serrated lesions was 13.2%.

Another BBT SimpleScreen™, which is not yet FDA-approved, analyzed circulating, cell-free DNA methylation patterns in 27,010 evaluable average-risk, asymptomatic adults ages 45–85 years undergoing screening colonoscopy.¹⁶ The sensitivity and specificity for CRC was 79.2% and 91.5%, respectively. Similar to Shield, the sensitivity for stage I CRC was low at 57.1%. The sensitivity for advanced precancerous lesions, a secondary endpoint, was 12.5% which did not meet the prespecified study criteria. 
 

Effectiveness and Cost Effectiveness

Modeling studies have evaluated novel noninvasive CRC screening tests compared to FIT and colonoscopy.^17-20 One compared a hypothetical BBT performed every 3 years that meets the minimum CMS threshold CRC sensitivity and specificity of 74% and 90%, respectively, to other established CRC screening tests beginning at age 45.¹⁷ Every 3-year BBT reduced CRC incidence and mortality by 40% and 52%, respectively compared to no screening. However, the reductions were much lower than yearly FIT (72% and 76%, respectively), every 10 year colonoscopy (79% and 81%, respectively), and triennial mt-sDNA (68% and 73%, respectively). The BBT resulted in fewer quality-adjusted life-years per person compared to the alternatives.

Additionally, FIT, colonoscopy, and mt-sDNA were less costly and more effective. Advanced precancerous lesion detection was a key measure for a test’s effectiveness. BBT characteristics would require a CRC sensitivity and specificity of >90% and 90%, respectively, and 80% sensitivity for advanced precancerous lesions at a cost of ≤$120–$140 to be cost-effective compared to FIT at comparable participation rates.

Another analysis simulated colorectal neoplasia progression and compared clinical effectiveness and cost between annual FIT, every 3 year stool mt-sRNA, every 3 year stool mt-sDNA tests, every 3 year stool Shield™; these outcomes were compared to colonoscopy every 10 years and no screening in adults ≥ age 45 over different adherence rates.¹⁹ At real-world adherence rates of 60%, colonoscopy prevented most CRC cases and associated deaths. FIT was the most cost-effective strategy at all adherence levels. Between the multi-target stool tests and Shield™, mt-sRNA was the most cost-effective. Compared to FIT, mt-sRNA reduced CRC cases and deaths by 1% and 14%.

The third study evaluated CRC incidence and mortality, quality-adjusted life-years and costs with annual FIT, colonoscopy every 10 years, mt- sDNA tests, mt-sRNA test, and BBTs.²⁰ The latest mt-sDNA (Colguard plus™) and mt-sRNA achieved benefits approaching FIT but the Shield™ test was substantially less effective. The authors hypothesized that if 15% of the population substituted Shield™ for current effective CRC screening strategies, an increase in CRC deaths would occur and require 9-10% of the unscreened population to uptake screening with Shield to avert the increases in CRC deaths due to the substitution effect.
 

Clinical Implications

The effectiveness of non-invasive screening strategies depends on their diagnostic performance, adherence, and ensuring a timely colonoscopy after a positive test. Two claims-based studies found 47.9% and 49% of patients underwent follow-up colonoscopy within 6 months of an abnormal stool or BBT CRC screening test, respectively.^21-22

Conclusions

Non-invasive stool mt-sDNA and mt-sRNA have higher effectiveness than the new BBTs. BBTs can lead to increased CRC mortality if substituted for the FDA and CMS-approved, USPSTF-endorsed, CRC screening modalities. If future BBTs increase their sensitivity for CRC (including early-stage CRC) and advanced precancerous lesions and decrease their cost, they may prove to have similar cost-effectiveness to stool-based tests. Currently, BBTs are not a substitute for colonoscopy or other stool tests and should be offered to patients who refuse other CRC screening modalities. A personalized, risk-adapted approach, paired with improved adherence and follow-up are essential to optimize the population-level impact of CRC screening and ensure equitable, effective cancer prevention.

Dr. Gupta is based at the Division of Gastroenterology and Hepatology, Department of Medicine, University of Maryland School of Medicine, Baltimore. Dr. Burke and Dr. Macaron are based at the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland, Ohio. Dr. Gupta and Dr. Macaron declared no conflicts of interest in regard to this article. Dr. Burke declared research support from Emtora Biosciences. She is a current consultant for Lumabridge, and has been a consultant for Sebela and Almirall. She also disclosed support from Myriad, Genzyme, Ferring, Merck, Sharp and Dohme, Abbvie, Salix, and Natera.

References

1. Benavidez GA, Sedani AE, Felder TM, Asare M, Rogers CR. Rural-urban disparities and trends in cancer screening: an analysis of Behavioral Risk Factor Surveillance System data (2018-2022). JNCI Cancer Spectr. 2024 Nov 1;8(6):pkae113

2. Galoosian A, Dai H, Croymans D, et al. Population Health Colorectal Cancer Screening Strategies in Adults Aged 45 to 49 Years: A Randomized Clinical Trial. JAMA. 2025 Aug 4:e2512049. doi: 10.1001/jama.2025.12049. Epub ahead of print. 

3. Pilonis ND, Bugajski M, Wieszczy P, et al. Participation in Competing Strategies for Colorectal Cancer Screening: A Randomized Health Services Study (PICCOLINO Study). Gastroenterology. 2021 Mar;160(4):1097-1105.

4. Shaukat A, Mongin SJ, Geisser MS, et al. Long-term mortality after screening for colorectal cancer. N Engl J Med. 2013;369(12):1106–1114.

5. Kronborg O, Fenger C, Olsen J, Jørgensen OD, Søndergaard O. Randomised study of screening for colorectal cancer with faecal-occult-blood test. Lancet. 1996 Nov 30;348(9040):1467-71. doi: 10.1016/S0140-6736(96)03430-7. PMID: 8942774.

6. Burke CA, Lieberman D, Feuerstein JD. AGA Clinical Practice Update on Approach to the Use of Noninvasive Colorectal Cancer Screening Options: Commentary. Gastroenterology. 2022 Mar;162(3):952-956. doi: 10.1053/j.gastro.2021.09.075. Epub 2022 Jan 28. PMID: 35094786.

7. Imperiale TF, Gruber RN Stump TE, et al. Performance characteristics of fecal immunochemical tests for colorectal cancer and advanced adenomatous polyps: a systematic review and meta-analysis. Ann Intern Med 2019; 170(5):319-329

8. Doubeni CA, Corley DA, Jensen CD, et al. Fecal Immunochemical Test Screening and Risk of Colorectal Cancer Death. JAMA Netw Open. 2024 Jul 1;7(7):e2423671. doi: 10.1001/jamanetworkopen.2024.23671. 

9. Chiu HM, Jen GH, Wang YW, et al. Long-term effectiveness of faecal immunochemical test screening for proximal and distal colorectal cancers. Gut. 2021 Dec;70(12):2321-2329. doi: 10.1136/gutjnl-2020-322545. Epub 2021 Jan 25.

10. Castells A, Quintero E, Bujanda L, et al; COLONPREV study investigators. Effect of invitation to colonoscopy versus fecal immunochemical test screening on colorectal cancer mortality (COLONPREV): a pragmatic, randomised, controlled, non-inferiority trial. Lancet. 2025;405(10486):1231–1239

11. Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(14):1287-1297

12. Imperiale TF, Porter K, Zella J, et al. Next-Generation Multitarget Stool DNA Test for Colorectal Cancer Screening. N Engl J Med. 2024 Mar 14;390(11):984-993

13. Barnell EK, Wurtzler EM, La Rocca J, et al. Multitarget Stool RNA Test for Colorectal Cancer Screening. JAMA. 2023 Nov 14;330(18):1760-1768. 

14. Church TR, Wandell M, Lofton-Day C, et al. Prospective evaluation of methylated SEPT9 in plasma for detection of asymptomatic colorectal cancer. Gut 2014; 63:317–325.

15. Chung DC, Gray DM 2nd, Singh H, et al. A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening. N Engl J Med. 2024 Mar 14;390(11):973-983.

16. Shaukat A, Burke CA, Chan AT, et al. Clinical Validation of a Circulating Tumor DNA-Based Blood Test to Screen for Colorectal Cancer. JAMA. 2025 Jul 1;334(1):56-63.

17. Ladabaum U, Mannalithara A, Weng Y, et al. Comparative Effectiveness and Cost-Effectiveness of Colorectal Cancer Screening with Blood-Based Biomarkers (Liquid Biopsy) vs Fecal Tests or Colonoscopy. Gastroenterology. 2024 Jul;167(2):378-391.

18. van den Puttelaar R, Nascimento de Lima P, Knudsen AB, et al. Effectiveness and cost-effectiveness of colorectal cancer screening with a blood test that meets the Centers for Medicare & Medicaid Services coverage decision. Gastroenterology 2024;167:368–377.

19. Shaukat A, Levin TR, Liang PS. Cost-effectiveness of Novel Noninvasive Screening Tests for Colorectal Neoplasia. Clin Gastroenterol Hepatol. 2025 Jun 23:S1542-3565(25)00525-7. doi: 10.1016/j.cgh.2025.06.006. Epub ahead of print. PMID: 40562290.

20. Ladabaum U, Mannalithara A, Schoen RE, Dominitz JA, Lieberman D. Projected Impact and Cost-Effectiveness of Novel Molecular Blood-Based or Stool-Based Screening Tests for Colorectal Cancer. Ann Intern Med. 2024 Dec;177(12):1610-1620.

20. Ciemins EL, Mohl JT, Moreno CA, Colangelo F, Smith RA, Barton M. Development of a Follow-Up Measure to Ensure Complete Screening for Colorectal Cancer. JAMA Netw Open. 2024 Mar 4;7(3):e242693. doi: 10.1001/jamanetworkopen.2024.2693. 

21. Zaki TA, Zhang NJ, Forbes SP, Raymond VM, Das AK, May FP. Colonoscopic Follow-up After Abnormal Blood-Based Colorectal Cancer Screening Results. Gastroenterology. 2025 Jul 21:S0016-5085(25)05775-0. doi: 10.1053/j.gastro.2025.07.019. Epub ahead of print. PMID: 40744392.

 

Introduction

Colorectal cancer (CRC) screening significantly reduces CRC incidence and mortality, but only 65% of eligible individuals report being up-to-date with screening.¹ Colonoscopy is the most widely used opportunistic screening method in the United States and is associated with many barriers to uptake. Providing patients a choice of colonoscopy and/or stool-based tests, improves screening adherence in randomized controlled trials.^2,3 Non-invasive screening options have expanded from stool occult blood and multi-target DNA tests, to multi-target stool RNA tests, and novel blood-based tests, the latter only U.S. Food and Drug Administration (FDA) approved for patients who refuse colonoscopy and stool-based tests. This review summarizes the test characteristics of stool and blood CRC screening options and provides guidance on clinical implications of their use.

Stool Occult Blood Tests

Guaiac-based fecal occult blood testing (gFOBT) significantly reduces CRC mortality by 33%-35% when implemented on an annual or biennial basis.^4,5 Fecal immunochemical testing (FIT) has supplanted gFOBT with advantages including independence from dietary restriction and medication-related interference, use of antibodies specific to human globin, and the need for only a single stool sample.

The most common threshold for a positive FIT in the U.S. is ≥ 20 micrograms (μg) of hemoglobin per gram (g) of stool. FIT is approved by the FDA as a qualitative positive or negative result based on a threshold value.⁶ A meta-analysis summarized test characteristics of commercially available FITs at various detection thresholds.⁷ The CRC sensitivity and specificity was 75% and 95% for ≥ 20 ug hemoglobin/g stool, and 91% and 90% for 10 ug hemoglobin/g stool, respectively. The sensitivity for advanced adenomas ranged from 25% at 20 μg/g to 40% at a 10 μg/g. Programmatic use of FIT in adults ages ≥ 50 years at 20 ug/g of stool, in cohort and case control studies, has been shown to significantly reduce CRC mortality by 33%-40% and advanced stage CRC by 34%.^8,9

Over 57,000 average-risk individuals ages 50–69 years were randomized to biennial FIT or one-time colonoscopy and followed for 10 years.¹⁰ CRC mortality and incidence was similar between the groups: 0.22% with FIT vs. 0.24% with colonoscopy and 1.13% with FIT vs. 1.22% with colonoscopy, respectively. Thus, confirming biennial FIT screening is non-inferior to one-time colonoscopy in important CRC-related outcomes.
 

Multi-Target Stool Tests

Two multitarget stool DNA tests (mt-sDNA) known as Cologuard™ and Cologuard Plus™ have been approved by the FDA. Both tests include a FIT (with a positivity threshold of 20 μg hemoglobin per gram of stool) combined with DNA methylation markers. The test result is qualitative, reported as a positive or negative. Cologuard™ markers include methylated BMP3, NDRG4, and mutant KRAS while Cologuard Plus™ assesses methylated LASS4, LRRC4, and PPP2R5C. The respective mt-sDNA tests were studied in 9989 of 12,776 and 20,176 of 26,758 average-risk individuals undergoing colonoscopy and the results were compared to a commercially available FIT (with a positivity threshold of 20 μg hemoglobin/gram of stool).^11,12 In both trials, the sensitivity for CRC and advanced precancerous lesions was higher with the mt-sDNA tests compared to FIT but had a significantly lower specificity for advanced precancerous lesions versus FIT (see Table 1). An age-related decline in specificity was noted in both trials with mt-sDNA, a trend not observed with FIT. This reduction may be attributed to age-related DNA methylation.

Multi-Target Stool RNA Test

A multi-target stool RNA test (mt-sRNA) commercially available as ColoSense™ is FDA-approved. It combines FIT (at a positivity threshold of 20 μg hemoglobin/gram of stool) with RNA-based stool markers. The combined results of the RNA markers, FIT, and smoking status provide a qualitative single test result. In the trial, 8,920 adults aged ≥45 underwent the mt-sRNA test and FIT followed by colonoscopy (13). The mt-sRNA showed higher sensitivity for CRC than FIT (94.4% versus 77.8%) and advanced adenomas (45.9% versus 28.9%) but lower CRC specificity (84.7% vs 94.7%) (Table 1). Unlike mt-sDNA-based tests, mt-sRNA showed consistent performance across age groups, addressing concerns about age-related declines in specificity attributed to DNA methylation. 
 

Blood-Based Tests

In 2014, the first blood-based (BBT) CRC screening test known as Epi proColon™ was FDA but not Centers for Medicare & Medicaid Services (CMS) approved for average-risk adults ≥50 years of age who are offered and refused other U.S Preventive Services Task Force (USPSTF) endorsed CRC screening tests. It is a qualitative test for detection of circulating methylated Septin 9 (mSeptin9). The accuracy of mSeptin9 to detect CRC was assessed in a subset of 7941 asymptomatic average risk adults undergoing screening colonoscopy.¹⁴ The sensitivity and specificity for CRC were 48% and 91.5%, respectively. The sensitivity for advanced adenomas was 11.2%. An increase in sensitivity to 63.9% and reduction in specificity to 88.4% for CRC was demonstrated in a sub-analysis of available samples where an additional (third) polymerase chain replicate was performed. Epi proColon™ is not currently reimbursed by Medicare and not endorsed in the latest USPSTF guidelines.

Technologic advancements have improved the detection of circulating tumor markers in the blood. The Shield™ BBT approved by the FDA in 2024 for average risk adults ≥ 45 years integrates three types of cfDNA data (epigenetic changes resulting in the aberrant methylation or fragmentation patterns, and genomic changes resulting in somatic mutations) into a positive or negative test result. In the trial, 22,877 average-risk, asymptomatic individuals ages 45–84 were enrolled and clinical validation was performed in 7,861 of the participants.¹⁵ The sensitivity for CRC was 83.1% which decreased to 55% for stage I tumors (see Table 1). CRC specificity was 89.6% and the sensitivity for advanced adenomas and large sessile serrated lesions was 13.2%.

Another BBT SimpleScreen™, which is not yet FDA-approved, analyzed circulating, cell-free DNA methylation patterns in 27,010 evaluable average-risk, asymptomatic adults ages 45–85 years undergoing screening colonoscopy.¹⁶ The sensitivity and specificity for CRC was 79.2% and 91.5%, respectively. Similar to Shield, the sensitivity for stage I CRC was low at 57.1%. The sensitivity for advanced precancerous lesions, a secondary endpoint, was 12.5% which did not meet the prespecified study criteria. 
 

Effectiveness and Cost Effectiveness

Modeling studies have evaluated novel noninvasive CRC screening tests compared to FIT and colonoscopy.^17-20 One compared a hypothetical BBT performed every 3 years that meets the minimum CMS threshold CRC sensitivity and specificity of 74% and 90%, respectively, to other established CRC screening tests beginning at age 45.¹⁷ Every 3-year BBT reduced CRC incidence and mortality by 40% and 52%, respectively compared to no screening. However, the reductions were much lower than yearly FIT (72% and 76%, respectively), every 10 year colonoscopy (79% and 81%, respectively), and triennial mt-sDNA (68% and 73%, respectively). The BBT resulted in fewer quality-adjusted life-years per person compared to the alternatives.

Additionally, FIT, colonoscopy, and mt-sDNA were less costly and more effective. Advanced precancerous lesion detection was a key measure for a test’s effectiveness. BBT characteristics would require a CRC sensitivity and specificity of >90% and 90%, respectively, and 80% sensitivity for advanced precancerous lesions at a cost of ≤$120–$140 to be cost-effective compared to FIT at comparable participation rates.

Another analysis simulated colorectal neoplasia progression and compared clinical effectiveness and cost between annual FIT, every 3 year stool mt-sRNA, every 3 year stool mt-sDNA tests, every 3 year stool Shield™; these outcomes were compared to colonoscopy every 10 years and no screening in adults ≥ age 45 over different adherence rates.¹⁹ At real-world adherence rates of 60%, colonoscopy prevented most CRC cases and associated deaths. FIT was the most cost-effective strategy at all adherence levels. Between the multi-target stool tests and Shield™, mt-sRNA was the most cost-effective. Compared to FIT, mt-sRNA reduced CRC cases and deaths by 1% and 14%.

The third study evaluated CRC incidence and mortality, quality-adjusted life-years and costs with annual FIT, colonoscopy every 10 years, mt- sDNA tests, mt-sRNA test, and BBTs.²⁰ The latest mt-sDNA (Colguard plus™) and mt-sRNA achieved benefits approaching FIT but the Shield™ test was substantially less effective. The authors hypothesized that if 15% of the population substituted Shield™ for current effective CRC screening strategies, an increase in CRC deaths would occur and require 9-10% of the unscreened population to uptake screening with Shield to avert the increases in CRC deaths due to the substitution effect.
 

Clinical Implications

The effectiveness of non-invasive screening strategies depends on their diagnostic performance, adherence, and ensuring a timely colonoscopy after a positive test. Two claims-based studies found 47.9% and 49% of patients underwent follow-up colonoscopy within 6 months of an abnormal stool or BBT CRC screening test, respectively.^21-22

Conclusions

Non-invasive stool mt-sDNA and mt-sRNA have higher effectiveness than the new BBTs. BBTs can lead to increased CRC mortality if substituted for the FDA and CMS-approved, USPSTF-endorsed, CRC screening modalities. If future BBTs increase their sensitivity for CRC (including early-stage CRC) and advanced precancerous lesions and decrease their cost, they may prove to have similar cost-effectiveness to stool-based tests. Currently, BBTs are not a substitute for colonoscopy or other stool tests and should be offered to patients who refuse other CRC screening modalities. A personalized, risk-adapted approach, paired with improved adherence and follow-up are essential to optimize the population-level impact of CRC screening and ensure equitable, effective cancer prevention.

Dr. Gupta is based at the Division of Gastroenterology and Hepatology, Department of Medicine, University of Maryland School of Medicine, Baltimore. Dr. Burke and Dr. Macaron are based at the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland, Ohio. Dr. Gupta and Dr. Macaron declared no conflicts of interest in regard to this article. Dr. Burke declared research support from Emtora Biosciences. She is a current consultant for Lumabridge, and has been a consultant for Sebela and Almirall. She also disclosed support from Myriad, Genzyme, Ferring, Merck, Sharp and Dohme, Abbvie, Salix, and Natera.

References

1. Benavidez GA, Sedani AE, Felder TM, Asare M, Rogers CR. Rural-urban disparities and trends in cancer screening: an analysis of Behavioral Risk Factor Surveillance System data (2018-2022). JNCI Cancer Spectr. 2024 Nov 1;8(6):pkae113

2. Galoosian A, Dai H, Croymans D, et al. Population Health Colorectal Cancer Screening Strategies in Adults Aged 45 to 49 Years: A Randomized Clinical Trial. JAMA. 2025 Aug 4:e2512049. doi: 10.1001/jama.2025.12049. Epub ahead of print. 

3. Pilonis ND, Bugajski M, Wieszczy P, et al. Participation in Competing Strategies for Colorectal Cancer Screening: A Randomized Health Services Study (PICCOLINO Study). Gastroenterology. 2021 Mar;160(4):1097-1105.

4. Shaukat A, Mongin SJ, Geisser MS, et al. Long-term mortality after screening for colorectal cancer. N Engl J Med. 2013;369(12):1106–1114.

5. Kronborg O, Fenger C, Olsen J, Jørgensen OD, Søndergaard O. Randomised study of screening for colorectal cancer with faecal-occult-blood test. Lancet. 1996 Nov 30;348(9040):1467-71. doi: 10.1016/S0140-6736(96)03430-7. PMID: 8942774.

6. Burke CA, Lieberman D, Feuerstein JD. AGA Clinical Practice Update on Approach to the Use of Noninvasive Colorectal Cancer Screening Options: Commentary. Gastroenterology. 2022 Mar;162(3):952-956. doi: 10.1053/j.gastro.2021.09.075. Epub 2022 Jan 28. PMID: 35094786.

7. Imperiale TF, Gruber RN Stump TE, et al. Performance characteristics of fecal immunochemical tests for colorectal cancer and advanced adenomatous polyps: a systematic review and meta-analysis. Ann Intern Med 2019; 170(5):319-329

8. Doubeni CA, Corley DA, Jensen CD, et al. Fecal Immunochemical Test Screening and Risk of Colorectal Cancer Death. JAMA Netw Open. 2024 Jul 1;7(7):e2423671. doi: 10.1001/jamanetworkopen.2024.23671. 

9. Chiu HM, Jen GH, Wang YW, et al. Long-term effectiveness of faecal immunochemical test screening for proximal and distal colorectal cancers. Gut. 2021 Dec;70(12):2321-2329. doi: 10.1136/gutjnl-2020-322545. Epub 2021 Jan 25.

10. Castells A, Quintero E, Bujanda L, et al; COLONPREV study investigators. Effect of invitation to colonoscopy versus fecal immunochemical test screening on colorectal cancer mortality (COLONPREV): a pragmatic, randomised, controlled, non-inferiority trial. Lancet. 2025;405(10486):1231–1239

11. Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(14):1287-1297

12. Imperiale TF, Porter K, Zella J, et al. Next-Generation Multitarget Stool DNA Test for Colorectal Cancer Screening. N Engl J Med. 2024 Mar 14;390(11):984-993

13. Barnell EK, Wurtzler EM, La Rocca J, et al. Multitarget Stool RNA Test for Colorectal Cancer Screening. JAMA. 2023 Nov 14;330(18):1760-1768. 

14. Church TR, Wandell M, Lofton-Day C, et al. Prospective evaluation of methylated SEPT9 in plasma for detection of asymptomatic colorectal cancer. Gut 2014; 63:317–325.

15. Chung DC, Gray DM 2nd, Singh H, et al. A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening. N Engl J Med. 2024 Mar 14;390(11):973-983.

16. Shaukat A, Burke CA, Chan AT, et al. Clinical Validation of a Circulating Tumor DNA-Based Blood Test to Screen for Colorectal Cancer. JAMA. 2025 Jul 1;334(1):56-63.

17. Ladabaum U, Mannalithara A, Weng Y, et al. Comparative Effectiveness and Cost-Effectiveness of Colorectal Cancer Screening with Blood-Based Biomarkers (Liquid Biopsy) vs Fecal Tests or Colonoscopy. Gastroenterology. 2024 Jul;167(2):378-391.

18. van den Puttelaar R, Nascimento de Lima P, Knudsen AB, et al. Effectiveness and cost-effectiveness of colorectal cancer screening with a blood test that meets the Centers for Medicare & Medicaid Services coverage decision. Gastroenterology 2024;167:368–377.

19. Shaukat A, Levin TR, Liang PS. Cost-effectiveness of Novel Noninvasive Screening Tests for Colorectal Neoplasia. Clin Gastroenterol Hepatol. 2025 Jun 23:S1542-3565(25)00525-7. doi: 10.1016/j.cgh.2025.06.006. Epub ahead of print. PMID: 40562290.

20. Ladabaum U, Mannalithara A, Schoen RE, Dominitz JA, Lieberman D. Projected Impact and Cost-Effectiveness of Novel Molecular Blood-Based or Stool-Based Screening Tests for Colorectal Cancer. Ann Intern Med. 2024 Dec;177(12):1610-1620.

20. Ciemins EL, Mohl JT, Moreno CA, Colangelo F, Smith RA, Barton M. Development of a Follow-Up Measure to Ensure Complete Screening for Colorectal Cancer. JAMA Netw Open. 2024 Mar 4;7(3):e242693. doi: 10.1001/jamanetworkopen.2024.2693. 

21. Zaki TA, Zhang NJ, Forbes SP, Raymond VM, Das AK, May FP. Colonoscopic Follow-up After Abnormal Blood-Based Colorectal Cancer Screening Results. Gastroenterology. 2025 Jul 21:S0016-5085(25)05775-0. doi: 10.1053/j.gastro.2025.07.019. Epub ahead of print. PMID: 40744392.

 

Introduction

Colorectal cancer (CRC) screening significantly reduces CRC incidence and mortality, but only 65% of eligible individuals report being up-to-date with screening.¹ Colonoscopy is the most widely used opportunistic screening method in the United States and is associated with many barriers to uptake. Providing patients a choice of colonoscopy and/or stool-based tests, improves screening adherence in randomized controlled trials.^2,3 Non-invasive screening options have expanded from stool occult blood and multi-target DNA tests, to multi-target stool RNA tests, and novel blood-based tests, the latter only U.S. Food and Drug Administration (FDA) approved for patients who refuse colonoscopy and stool-based tests. This review summarizes the test characteristics of stool and blood CRC screening options and provides guidance on clinical implications of their use.

Stool Occult Blood Tests

Guaiac-based fecal occult blood testing (gFOBT) significantly reduces CRC mortality by 33%-35% when implemented on an annual or biennial basis.^4,5 Fecal immunochemical testing (FIT) has supplanted gFOBT with advantages including independence from dietary restriction and medication-related interference, use of antibodies specific to human globin, and the need for only a single stool sample.

The most common threshold for a positive FIT in the U.S. is ≥ 20 micrograms (μg) of hemoglobin per gram (g) of stool. FIT is approved by the FDA as a qualitative positive or negative result based on a threshold value.⁶ A meta-analysis summarized test characteristics of commercially available FITs at various detection thresholds.⁷ The CRC sensitivity and specificity was 75% and 95% for ≥ 20 ug hemoglobin/g stool, and 91% and 90% for 10 ug hemoglobin/g stool, respectively. The sensitivity for advanced adenomas ranged from 25% at 20 μg/g to 40% at a 10 μg/g. Programmatic use of FIT in adults ages ≥ 50 years at 20 ug/g of stool, in cohort and case control studies, has been shown to significantly reduce CRC mortality by 33%-40% and advanced stage CRC by 34%.^8,9

Over 57,000 average-risk individuals ages 50–69 years were randomized to biennial FIT or one-time colonoscopy and followed for 10 years.¹⁰ CRC mortality and incidence was similar between the groups: 0.22% with FIT vs. 0.24% with colonoscopy and 1.13% with FIT vs. 1.22% with colonoscopy, respectively. Thus, confirming biennial FIT screening is non-inferior to one-time colonoscopy in important CRC-related outcomes.
 

Multi-Target Stool Tests

Two multitarget stool DNA tests (mt-sDNA) known as Cologuard™ and Cologuard Plus™ have been approved by the FDA. Both tests include a FIT (with a positivity threshold of 20 μg hemoglobin per gram of stool) combined with DNA methylation markers. The test result is qualitative, reported as a positive or negative. Cologuard™ markers include methylated BMP3, NDRG4, and mutant KRAS while Cologuard Plus™ assesses methylated LASS4, LRRC4, and PPP2R5C. The respective mt-sDNA tests were studied in 9989 of 12,776 and 20,176 of 26,758 average-risk individuals undergoing colonoscopy and the results were compared to a commercially available FIT (with a positivity threshold of 20 μg hemoglobin/gram of stool).^11,12 In both trials, the sensitivity for CRC and advanced precancerous lesions was higher with the mt-sDNA tests compared to FIT but had a significantly lower specificity for advanced precancerous lesions versus FIT (see Table 1). An age-related decline in specificity was noted in both trials with mt-sDNA, a trend not observed with FIT. This reduction may be attributed to age-related DNA methylation.

Multi-Target Stool RNA Test

A multi-target stool RNA test (mt-sRNA) commercially available as ColoSense™ is FDA-approved. It combines FIT (at a positivity threshold of 20 μg hemoglobin/gram of stool) with RNA-based stool markers. The combined results of the RNA markers, FIT, and smoking status provide a qualitative single test result. In the trial, 8,920 adults aged ≥45 underwent the mt-sRNA test and FIT followed by colonoscopy (13). The mt-sRNA showed higher sensitivity for CRC than FIT (94.4% versus 77.8%) and advanced adenomas (45.9% versus 28.9%) but lower CRC specificity (84.7% vs 94.7%) (Table 1). Unlike mt-sDNA-based tests, mt-sRNA showed consistent performance across age groups, addressing concerns about age-related declines in specificity attributed to DNA methylation. 
 

Blood-Based Tests

In 2014, the first blood-based (BBT) CRC screening test known as Epi proColon™ was FDA but not Centers for Medicare & Medicaid Services (CMS) approved for average-risk adults ≥50 years of age who are offered and refused other U.S Preventive Services Task Force (USPSTF) endorsed CRC screening tests. It is a qualitative test for detection of circulating methylated Septin 9 (mSeptin9). The accuracy of mSeptin9 to detect CRC was assessed in a subset of 7941 asymptomatic average risk adults undergoing screening colonoscopy.¹⁴ The sensitivity and specificity for CRC were 48% and 91.5%, respectively. The sensitivity for advanced adenomas was 11.2%. An increase in sensitivity to 63.9% and reduction in specificity to 88.4% for CRC was demonstrated in a sub-analysis of available samples where an additional (third) polymerase chain replicate was performed. Epi proColon™ is not currently reimbursed by Medicare and not endorsed in the latest USPSTF guidelines.

Technologic advancements have improved the detection of circulating tumor markers in the blood. The Shield™ BBT approved by the FDA in 2024 for average risk adults ≥ 45 years integrates three types of cfDNA data (epigenetic changes resulting in the aberrant methylation or fragmentation patterns, and genomic changes resulting in somatic mutations) into a positive or negative test result. In the trial, 22,877 average-risk, asymptomatic individuals ages 45–84 were enrolled and clinical validation was performed in 7,861 of the participants.¹⁵ The sensitivity for CRC was 83.1% which decreased to 55% for stage I tumors (see Table 1). CRC specificity was 89.6% and the sensitivity for advanced adenomas and large sessile serrated lesions was 13.2%.

Another BBT SimpleScreen™, which is not yet FDA-approved, analyzed circulating, cell-free DNA methylation patterns in 27,010 evaluable average-risk, asymptomatic adults ages 45–85 years undergoing screening colonoscopy.¹⁶ The sensitivity and specificity for CRC was 79.2% and 91.5%, respectively. Similar to Shield, the sensitivity for stage I CRC was low at 57.1%. The sensitivity for advanced precancerous lesions, a secondary endpoint, was 12.5% which did not meet the prespecified study criteria. 
 

Effectiveness and Cost Effectiveness

Modeling studies have evaluated novel noninvasive CRC screening tests compared to FIT and colonoscopy.^17-20 One compared a hypothetical BBT performed every 3 years that meets the minimum CMS threshold CRC sensitivity and specificity of 74% and 90%, respectively, to other established CRC screening tests beginning at age 45.¹⁷ Every 3-year BBT reduced CRC incidence and mortality by 40% and 52%, respectively compared to no screening. However, the reductions were much lower than yearly FIT (72% and 76%, respectively), every 10 year colonoscopy (79% and 81%, respectively), and triennial mt-sDNA (68% and 73%, respectively). The BBT resulted in fewer quality-adjusted life-years per person compared to the alternatives.

Additionally, FIT, colonoscopy, and mt-sDNA were less costly and more effective. Advanced precancerous lesion detection was a key measure for a test’s effectiveness. BBT characteristics would require a CRC sensitivity and specificity of >90% and 90%, respectively, and 80% sensitivity for advanced precancerous lesions at a cost of ≤$120–$140 to be cost-effective compared to FIT at comparable participation rates.

Another analysis simulated colorectal neoplasia progression and compared clinical effectiveness and cost between annual FIT, every 3 year stool mt-sRNA, every 3 year stool mt-sDNA tests, every 3 year stool Shield™; these outcomes were compared to colonoscopy every 10 years and no screening in adults ≥ age 45 over different adherence rates.¹⁹ At real-world adherence rates of 60%, colonoscopy prevented most CRC cases and associated deaths. FIT was the most cost-effective strategy at all adherence levels. Between the multi-target stool tests and Shield™, mt-sRNA was the most cost-effective. Compared to FIT, mt-sRNA reduced CRC cases and deaths by 1% and 14%.

The third study evaluated CRC incidence and mortality, quality-adjusted life-years and costs with annual FIT, colonoscopy every 10 years, mt- sDNA tests, mt-sRNA test, and BBTs.²⁰ The latest mt-sDNA (Colguard plus™) and mt-sRNA achieved benefits approaching FIT but the Shield™ test was substantially less effective. The authors hypothesized that if 15% of the population substituted Shield™ for current effective CRC screening strategies, an increase in CRC deaths would occur and require 9-10% of the unscreened population to uptake screening with Shield to avert the increases in CRC deaths due to the substitution effect.
 

Clinical Implications

The effectiveness of non-invasive screening strategies depends on their diagnostic performance, adherence, and ensuring a timely colonoscopy after a positive test. Two claims-based studies found 47.9% and 49% of patients underwent follow-up colonoscopy within 6 months of an abnormal stool or BBT CRC screening test, respectively.^21-22

Conclusions

Non-invasive stool mt-sDNA and mt-sRNA have higher effectiveness than the new BBTs. BBTs can lead to increased CRC mortality if substituted for the FDA and CMS-approved, USPSTF-endorsed, CRC screening modalities. If future BBTs increase their sensitivity for CRC (including early-stage CRC) and advanced precancerous lesions and decrease their cost, they may prove to have similar cost-effectiveness to stool-based tests. Currently, BBTs are not a substitute for colonoscopy or other stool tests and should be offered to patients who refuse other CRC screening modalities. A personalized, risk-adapted approach, paired with improved adherence and follow-up are essential to optimize the population-level impact of CRC screening and ensure equitable, effective cancer prevention.

Dr. Gupta is based at the Division of Gastroenterology and Hepatology, Department of Medicine, University of Maryland School of Medicine, Baltimore. Dr. Burke and Dr. Macaron are based at the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland, Ohio. Dr. Gupta and Dr. Macaron declared no conflicts of interest in regard to this article. Dr. Burke declared research support from Emtora Biosciences. She is a current consultant for Lumabridge, and has been a consultant for Sebela and Almirall. She also disclosed support from Myriad, Genzyme, Ferring, Merck, Sharp and Dohme, Abbvie, Salix, and Natera.

References

1. Benavidez GA, Sedani AE, Felder TM, Asare M, Rogers CR. Rural-urban disparities and trends in cancer screening: an analysis of Behavioral Risk Factor Surveillance System data (2018-2022). JNCI Cancer Spectr. 2024 Nov 1;8(6):pkae113

2. Galoosian A, Dai H, Croymans D, et al. Population Health Colorectal Cancer Screening Strategies in Adults Aged 45 to 49 Years: A Randomized Clinical Trial. JAMA. 2025 Aug 4:e2512049. doi: 10.1001/jama.2025.12049. Epub ahead of print. 

3. Pilonis ND, Bugajski M, Wieszczy P, et al. Participation in Competing Strategies for Colorectal Cancer Screening: A Randomized Health Services Study (PICCOLINO Study). Gastroenterology. 2021 Mar;160(4):1097-1105.

4. Shaukat A, Mongin SJ, Geisser MS, et al. Long-term mortality after screening for colorectal cancer. N Engl J Med. 2013;369(12):1106–1114.

5. Kronborg O, Fenger C, Olsen J, Jørgensen OD, Søndergaard O. Randomised study of screening for colorectal cancer with faecal-occult-blood test. Lancet. 1996 Nov 30;348(9040):1467-71. doi: 10.1016/S0140-6736(96)03430-7. PMID: 8942774.

6. Burke CA, Lieberman D, Feuerstein JD. AGA Clinical Practice Update on Approach to the Use of Noninvasive Colorectal Cancer Screening Options: Commentary. Gastroenterology. 2022 Mar;162(3):952-956. doi: 10.1053/j.gastro.2021.09.075. Epub 2022 Jan 28. PMID: 35094786.

7. Imperiale TF, Gruber RN Stump TE, et al. Performance characteristics of fecal immunochemical tests for colorectal cancer and advanced adenomatous polyps: a systematic review and meta-analysis. Ann Intern Med 2019; 170(5):319-329

8. Doubeni CA, Corley DA, Jensen CD, et al. Fecal Immunochemical Test Screening and Risk of Colorectal Cancer Death. JAMA Netw Open. 2024 Jul 1;7(7):e2423671. doi: 10.1001/jamanetworkopen.2024.23671. 

9. Chiu HM, Jen GH, Wang YW, et al. Long-term effectiveness of faecal immunochemical test screening for proximal and distal colorectal cancers. Gut. 2021 Dec;70(12):2321-2329. doi: 10.1136/gutjnl-2020-322545. Epub 2021 Jan 25.

10. Castells A, Quintero E, Bujanda L, et al; COLONPREV study investigators. Effect of invitation to colonoscopy versus fecal immunochemical test screening on colorectal cancer mortality (COLONPREV): a pragmatic, randomised, controlled, non-inferiority trial. Lancet. 2025;405(10486):1231–1239

11. Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(14):1287-1297

12. Imperiale TF, Porter K, Zella J, et al. Next-Generation Multitarget Stool DNA Test for Colorectal Cancer Screening. N Engl J Med. 2024 Mar 14;390(11):984-993

13. Barnell EK, Wurtzler EM, La Rocca J, et al. Multitarget Stool RNA Test for Colorectal Cancer Screening. JAMA. 2023 Nov 14;330(18):1760-1768. 

14. Church TR, Wandell M, Lofton-Day C, et al. Prospective evaluation of methylated SEPT9 in plasma for detection of asymptomatic colorectal cancer. Gut 2014; 63:317–325.

15. Chung DC, Gray DM 2nd, Singh H, et al. A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening. N Engl J Med. 2024 Mar 14;390(11):973-983.

16. Shaukat A, Burke CA, Chan AT, et al. Clinical Validation of a Circulating Tumor DNA-Based Blood Test to Screen for Colorectal Cancer. JAMA. 2025 Jul 1;334(1):56-63.

17. Ladabaum U, Mannalithara A, Weng Y, et al. Comparative Effectiveness and Cost-Effectiveness of Colorectal Cancer Screening with Blood-Based Biomarkers (Liquid Biopsy) vs Fecal Tests or Colonoscopy. Gastroenterology. 2024 Jul;167(2):378-391.

18. van den Puttelaar R, Nascimento de Lima P, Knudsen AB, et al. Effectiveness and cost-effectiveness of colorectal cancer screening with a blood test that meets the Centers for Medicare & Medicaid Services coverage decision. Gastroenterology 2024;167:368–377.

19. Shaukat A, Levin TR, Liang PS. Cost-effectiveness of Novel Noninvasive Screening Tests for Colorectal Neoplasia. Clin Gastroenterol Hepatol. 2025 Jun 23:S1542-3565(25)00525-7. doi: 10.1016/j.cgh.2025.06.006. Epub ahead of print. PMID: 40562290.

20. Ladabaum U, Mannalithara A, Schoen RE, Dominitz JA, Lieberman D. Projected Impact and Cost-Effectiveness of Novel Molecular Blood-Based or Stool-Based Screening Tests for Colorectal Cancer. Ann Intern Med. 2024 Dec;177(12):1610-1620.

20. Ciemins EL, Mohl JT, Moreno CA, Colangelo F, Smith RA, Barton M. Development of a Follow-Up Measure to Ensure Complete Screening for Colorectal Cancer. JAMA Netw Open. 2024 Mar 4;7(3):e242693. doi: 10.1001/jamanetworkopen.2024.2693. 

21. Zaki TA, Zhang NJ, Forbes SP, Raymond VM, Das AK, May FP. Colonoscopic Follow-up After Abnormal Blood-Based Colorectal Cancer Screening Results. Gastroenterology. 2025 Jul 21:S0016-5085(25)05775-0. doi: 10.1053/j.gastro.2025.07.019. Epub ahead of print. PMID: 40744392.

 

TOPLINE:

Message-based psychotherapy (MBP), which uses asynchronous emails or texts, showed effectiveness comparable with that of video-based psychotherapy (VBP) for the treatment of depression on a commercial digital mental health platform, a new study showed.

METHODOLOGY:

• Investigators conducted a pragmatic sequential multiple-assignment randomized clinical trial from 2022 to 2024 involving 850 adult patients with a diagnosis of depression (mean age, 34 years; 66% women; 60% White, 22% Black and 14% Hispanic).
• Patients were initially randomly assigned to receive weekly MBP (n = 423) or VBP (n = 427), with nonresponders randomly assigned at week 6 to receive combination therapy of MBP plus weekly or monthly VBP. All patients received treatment for up to 12 weeks.
• Primary outcomes included depression severity measured by the 9-item Patient Health Questionnaire (PHQ-9), social functioning measured by the Quality of Life in Neurological Disorders 8-item tool, response to treatment (≥ 50% reduction in PHQ-9 total score or Clinical Global Impressions-Improvement score ≤ 2), and remissions (PHQ-9 score < 5).
• Secondary outcomes were treating disengagement, therapeutic alliance measured on the Working Alliance Inventory-Short Revised, quality of care in the past 4 weeks, and treatment satisfaction.

TAKEAWAY:

• Rates of response (47.5% and 47.2%, respectively) and remission (31.4% and 30.3%, respectively) were not significantly different at week 12 between the MBP and VBP groups or for nonresponders rerandomized to either group.
• There were also no significant differences in depression change scores between the MBP and VBP groups or for nonresponders rerandomized to either group.
• Treatment disengagement by week 5 was significantly higher in the VBP vs MBP group (21.3% vs 13.2%; P = .003); VBP responders had stronger initial therapeutic alliance at week 4 than MBP responders (P < .001).
• No significant differences were observed in the quality of care among those who responded only after the second randomization to MBP or VBP.

IN PRACTICE:

"Findings reinforced MBP as viable alternative to VBP. Broader insurance reimbursement for MBP could improve access to evidence-based care," the investigators wrote.

SOURCE:

The study was led by Michael D. Pullmann, PhD, School of Medicine, University of Washington, Seattle. It was published online on October 30 in JAMA Network Open.

LIMITATIONS:

The absence of a waiting list or a no-treatment control group made it difficult to rule out regression to the mean as an explanation for improvements. Additionally, missing data may have affected the robustness of some findings.

DISCLOSURES:

The research was funded by the National Institute of Mental Health. Several investigators reported having financial ties with various sources. Details are provided in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article first appeared on Medscape.com.

TOPLINE:

Message-based psychotherapy (MBP), which uses asynchronous emails or texts, showed effectiveness comparable with that of video-based psychotherapy (VBP) for the treatment of depression on a commercial digital mental health platform, a new study showed.

METHODOLOGY:

• Investigators conducted a pragmatic sequential multiple-assignment randomized clinical trial from 2022 to 2024 involving 850 adult patients with a diagnosis of depression (mean age, 34 years; 66% women; 60% White, 22% Black and 14% Hispanic).
• Patients were initially randomly assigned to receive weekly MBP (n = 423) or VBP (n = 427), with nonresponders randomly assigned at week 6 to receive combination therapy of MBP plus weekly or monthly VBP. All patients received treatment for up to 12 weeks.
• Primary outcomes included depression severity measured by the 9-item Patient Health Questionnaire (PHQ-9), social functioning measured by the Quality of Life in Neurological Disorders 8-item tool, response to treatment (≥ 50% reduction in PHQ-9 total score or Clinical Global Impressions-Improvement score ≤ 2), and remissions (PHQ-9 score < 5).
• Secondary outcomes were treating disengagement, therapeutic alliance measured on the Working Alliance Inventory-Short Revised, quality of care in the past 4 weeks, and treatment satisfaction.

TAKEAWAY:

• Rates of response (47.5% and 47.2%, respectively) and remission (31.4% and 30.3%, respectively) were not significantly different at week 12 between the MBP and VBP groups or for nonresponders rerandomized to either group.
• There were also no significant differences in depression change scores between the MBP and VBP groups or for nonresponders rerandomized to either group.
• Treatment disengagement by week 5 was significantly higher in the VBP vs MBP group (21.3% vs 13.2%; P = .003); VBP responders had stronger initial therapeutic alliance at week 4 than MBP responders (P < .001).
• No significant differences were observed in the quality of care among those who responded only after the second randomization to MBP or VBP.

IN PRACTICE:

"Findings reinforced MBP as viable alternative to VBP. Broader insurance reimbursement for MBP could improve access to evidence-based care," the investigators wrote.

SOURCE:

The study was led by Michael D. Pullmann, PhD, School of Medicine, University of Washington, Seattle. It was published online on October 30 in JAMA Network Open.

LIMITATIONS:

The absence of a waiting list or a no-treatment control group made it difficult to rule out regression to the mean as an explanation for improvements. Additionally, missing data may have affected the robustness of some findings.

DISCLOSURES:

The research was funded by the National Institute of Mental Health. Several investigators reported having financial ties with various sources. Details are provided in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article first appeared on Medscape.com.

TOPLINE:

Message-based psychotherapy (MBP), which uses asynchronous emails or texts, showed effectiveness comparable with that of video-based psychotherapy (VBP) for the treatment of depression on a commercial digital mental health platform, a new study showed.

METHODOLOGY:

• Investigators conducted a pragmatic sequential multiple-assignment randomized clinical trial from 2022 to 2024 involving 850 adult patients with a diagnosis of depression (mean age, 34 years; 66% women; 60% White, 22% Black and 14% Hispanic).
• Patients were initially randomly assigned to receive weekly MBP (n = 423) or VBP (n = 427), with nonresponders randomly assigned at week 6 to receive combination therapy of MBP plus weekly or monthly VBP. All patients received treatment for up to 12 weeks.
• Primary outcomes included depression severity measured by the 9-item Patient Health Questionnaire (PHQ-9), social functioning measured by the Quality of Life in Neurological Disorders 8-item tool, response to treatment (≥ 50% reduction in PHQ-9 total score or Clinical Global Impressions-Improvement score ≤ 2), and remissions (PHQ-9 score < 5).
• Secondary outcomes were treating disengagement, therapeutic alliance measured on the Working Alliance Inventory-Short Revised, quality of care in the past 4 weeks, and treatment satisfaction.

TAKEAWAY:

• Rates of response (47.5% and 47.2%, respectively) and remission (31.4% and 30.3%, respectively) were not significantly different at week 12 between the MBP and VBP groups or for nonresponders rerandomized to either group.
• There were also no significant differences in depression change scores between the MBP and VBP groups or for nonresponders rerandomized to either group.
• Treatment disengagement by week 5 was significantly higher in the VBP vs MBP group (21.3% vs 13.2%; P = .003); VBP responders had stronger initial therapeutic alliance at week 4 than MBP responders (P < .001).
• No significant differences were observed in the quality of care among those who responded only after the second randomization to MBP or VBP.

IN PRACTICE:

"Findings reinforced MBP as viable alternative to VBP. Broader insurance reimbursement for MBP could improve access to evidence-based care," the investigators wrote.

SOURCE:

The study was led by Michael D. Pullmann, PhD, School of Medicine, University of Washington, Seattle. It was published online on October 30 in JAMA Network Open.

LIMITATIONS:

The absence of a waiting list or a no-treatment control group made it difficult to rule out regression to the mean as an explanation for improvements. Additionally, missing data may have affected the robustness of some findings.

DISCLOSURES:

The research was funded by the National Institute of Mental Health. Several investigators reported having financial ties with various sources. Details are provided in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article first appeared on Medscape.com.

Treatment with a GLP-1 receptor agonist (RA) may offer a survival advantage in patients with colon cancer and obesity.

In a real-world analysis of nearly 7000 patients with colon cancer, those taking a GLP-1 RA were less than half as likely to die within 5 years compared with those who weren’t on a GLP-1 drug.

The association between GLP-1 exposure and lower 5–year mortality in colon cancer was “robust” and appeared to be concentrated in patients with severe obesity (BMI ≥ 35), lead investigator Raphael E. Cuomo, PhD, with University of California San Diego, told this news organization.

The apparent protective effect “persisted after controlling for differences in disease severity and demographics, as well as differences in circulating carcinoembryonic antigen, a biomarker of disease aggressiveness,” Cuomo said.

The study was published online in Cancer Investigation.
 

Effects Beyond Glucose-Lowering

Colon cancer remains a major global cause of cancer-related deaths, and obesity is both a risk factor and a driver of worse outcomes.

Beyond regulating blood sugar, GLP-1 drugs reduce systemic inflammation, improve insulin sensitivity, and promote weight loss. Prior preclinical work has also suggested they may prevent cancer cell growth, trigger cancer cell death, and reshape the tumor microenvironment.

To investigate further, Cuomo analyzed electronic health records of 6871 patients diagnosed with primary colon cancer before 2019 — of which 103 had at least 1 documented prescription for a GLP-1 drug within 5 years of diagnosis.

Five–year mortality was significantly lower in GLP-1 RA users than in nonusers (15.5% vs 37.1%; P < .001). A significant reduction in 5–year mortality among GLP-1 RA users was evident in an unadjusted model (odds ratio [OR], 0.38; P < .001) and persisted in fully adjusted models (OR, 0.28; P < .001).

When stratified by BMI, the odds of 5-year mortality with GLP-1 use was reduced only in patients with Class II obesity (BMI ≥ 35: fully adjusted hazard ratio [HR], 0.051; P = .004). In this group, fully adjusted hazard ratios suggested markedly lower risk for death (HR, 0.07; P = .009).

Beyond mortality, GLP-1 users also experienced fewer late cardiovascular events and had fewer markers of advanced colon cancer progression in the final months of follow-up, “which suggests that GLP-1 drugs exert benefits through both oncologic and cardiometabolic pathways,” Cuomo told this news organization.
 

Intriguing and Promising — but Further Studies Needed

“To further study the potential of GLP-1 therapy as an adjunct to standard care in colon cancer, randomized trials should be conducted with stratification by BMI, diabetes status, and disease severity, with endpoints spanning overall and cancerspecific survival and major cardiovascular events,” Cuomo said.

“We also need prospective translational studies integrating dosing/timing, adherence, tumor genomics, and serial biomarkers (including ctDNA and metabolic panels) to elucidate mechanisms, assess the role of adiposity and insulin resistance, and identify the patient subgroups most likely to benefit,” he noted.

For now, GLP1 medications are an option in “eligible colon cancer patients with severe obesity or diabetes who meet standard metabolic indications,” Cuomo told this news organization.

Commenting on this study for this news organization, David Greenwald, MD, director of Clinical Gastroenterology and Endoscopy at Icahn School of Medicine at Mount Sinai Hospital in New York City, noted “other studies have showed a lower risk of developing colorectal cancer in the first place and then improved survival.”

Greenwald cited a recent study that found people with diabetes who took GLP-1 RAs had a 44% lower risk of developing colorectal cancer than those who took insulin, and a 25% lower risk than those who took metformin.

The effects of GLP-1s in colon cancer are “very intriguing and very promising but more research is needed to confirm whether this is really true and the mechanisms behind it,” said Greenwald.

In terms of the lowering risk of developing colorectal cancer, “probably first and foremost is that the drugs are really effective in promoting weight loss. And if you can reduce obesity in the population, you do all sorts of good things — reduce diabetes, reduce heart disease, and maybe reduce colorectal cancer,” Greenwald said.

This study had no specific funding. Cuomo and Greenwald had no relevant disclosures.

A version of this article first appeared on Medscape.com.

Treatment with a GLP-1 receptor agonist (RA) may offer a survival advantage in patients with colon cancer and obesity.

In a real-world analysis of nearly 7000 patients with colon cancer, those taking a GLP-1 RA were less than half as likely to die within 5 years compared with those who weren’t on a GLP-1 drug.

The association between GLP-1 exposure and lower 5–year mortality in colon cancer was “robust” and appeared to be concentrated in patients with severe obesity (BMI ≥ 35), lead investigator Raphael E. Cuomo, PhD, with University of California San Diego, told this news organization.

The apparent protective effect “persisted after controlling for differences in disease severity and demographics, as well as differences in circulating carcinoembryonic antigen, a biomarker of disease aggressiveness,” Cuomo said.

The study was published online in Cancer Investigation.
 

Effects Beyond Glucose-Lowering

Colon cancer remains a major global cause of cancer-related deaths, and obesity is both a risk factor and a driver of worse outcomes.

Beyond regulating blood sugar, GLP-1 drugs reduce systemic inflammation, improve insulin sensitivity, and promote weight loss. Prior preclinical work has also suggested they may prevent cancer cell growth, trigger cancer cell death, and reshape the tumor microenvironment.

To investigate further, Cuomo analyzed electronic health records of 6871 patients diagnosed with primary colon cancer before 2019 — of which 103 had at least 1 documented prescription for a GLP-1 drug within 5 years of diagnosis.

Five–year mortality was significantly lower in GLP-1 RA users than in nonusers (15.5% vs 37.1%; P < .001). A significant reduction in 5–year mortality among GLP-1 RA users was evident in an unadjusted model (odds ratio [OR], 0.38; P < .001) and persisted in fully adjusted models (OR, 0.28; P < .001).

When stratified by BMI, the odds of 5-year mortality with GLP-1 use was reduced only in patients with Class II obesity (BMI ≥ 35: fully adjusted hazard ratio [HR], 0.051; P = .004). In this group, fully adjusted hazard ratios suggested markedly lower risk for death (HR, 0.07; P = .009).

Beyond mortality, GLP-1 users also experienced fewer late cardiovascular events and had fewer markers of advanced colon cancer progression in the final months of follow-up, “which suggests that GLP-1 drugs exert benefits through both oncologic and cardiometabolic pathways,” Cuomo told this news organization.
 

Intriguing and Promising — but Further Studies Needed

“To further study the potential of GLP-1 therapy as an adjunct to standard care in colon cancer, randomized trials should be conducted with stratification by BMI, diabetes status, and disease severity, with endpoints spanning overall and cancerspecific survival and major cardiovascular events,” Cuomo said.

“We also need prospective translational studies integrating dosing/timing, adherence, tumor genomics, and serial biomarkers (including ctDNA and metabolic panels) to elucidate mechanisms, assess the role of adiposity and insulin resistance, and identify the patient subgroups most likely to benefit,” he noted.

For now, GLP1 medications are an option in “eligible colon cancer patients with severe obesity or diabetes who meet standard metabolic indications,” Cuomo told this news organization.

Commenting on this study for this news organization, David Greenwald, MD, director of Clinical Gastroenterology and Endoscopy at Icahn School of Medicine at Mount Sinai Hospital in New York City, noted “other studies have showed a lower risk of developing colorectal cancer in the first place and then improved survival.”

Greenwald cited a recent study that found people with diabetes who took GLP-1 RAs had a 44% lower risk of developing colorectal cancer than those who took insulin, and a 25% lower risk than those who took metformin.

The effects of GLP-1s in colon cancer are “very intriguing and very promising but more research is needed to confirm whether this is really true and the mechanisms behind it,” said Greenwald.

In terms of the lowering risk of developing colorectal cancer, “probably first and foremost is that the drugs are really effective in promoting weight loss. And if you can reduce obesity in the population, you do all sorts of good things — reduce diabetes, reduce heart disease, and maybe reduce colorectal cancer,” Greenwald said.

This study had no specific funding. Cuomo and Greenwald had no relevant disclosures.

A version of this article first appeared on Medscape.com.

Treatment with a GLP-1 receptor agonist (RA) may offer a survival advantage in patients with colon cancer and obesity.

In a real-world analysis of nearly 7000 patients with colon cancer, those taking a GLP-1 RA were less than half as likely to die within 5 years compared with those who weren’t on a GLP-1 drug.

The association between GLP-1 exposure and lower 5–year mortality in colon cancer was “robust” and appeared to be concentrated in patients with severe obesity (BMI ≥ 35), lead investigator Raphael E. Cuomo, PhD, with University of California San Diego, told this news organization.

The apparent protective effect “persisted after controlling for differences in disease severity and demographics, as well as differences in circulating carcinoembryonic antigen, a biomarker of disease aggressiveness,” Cuomo said.

The study was published online in Cancer Investigation.
 

Effects Beyond Glucose-Lowering

Colon cancer remains a major global cause of cancer-related deaths, and obesity is both a risk factor and a driver of worse outcomes.

Beyond regulating blood sugar, GLP-1 drugs reduce systemic inflammation, improve insulin sensitivity, and promote weight loss. Prior preclinical work has also suggested they may prevent cancer cell growth, trigger cancer cell death, and reshape the tumor microenvironment.

To investigate further, Cuomo analyzed electronic health records of 6871 patients diagnosed with primary colon cancer before 2019 — of which 103 had at least 1 documented prescription for a GLP-1 drug within 5 years of diagnosis.

Five–year mortality was significantly lower in GLP-1 RA users than in nonusers (15.5% vs 37.1%; P < .001). A significant reduction in 5–year mortality among GLP-1 RA users was evident in an unadjusted model (odds ratio [OR], 0.38; P < .001) and persisted in fully adjusted models (OR, 0.28; P < .001).

When stratified by BMI, the odds of 5-year mortality with GLP-1 use was reduced only in patients with Class II obesity (BMI ≥ 35: fully adjusted hazard ratio [HR], 0.051; P = .004). In this group, fully adjusted hazard ratios suggested markedly lower risk for death (HR, 0.07; P = .009).

Beyond mortality, GLP-1 users also experienced fewer late cardiovascular events and had fewer markers of advanced colon cancer progression in the final months of follow-up, “which suggests that GLP-1 drugs exert benefits through both oncologic and cardiometabolic pathways,” Cuomo told this news organization.
 

Intriguing and Promising — but Further Studies Needed

“To further study the potential of GLP-1 therapy as an adjunct to standard care in colon cancer, randomized trials should be conducted with stratification by BMI, diabetes status, and disease severity, with endpoints spanning overall and cancerspecific survival and major cardiovascular events,” Cuomo said.

“We also need prospective translational studies integrating dosing/timing, adherence, tumor genomics, and serial biomarkers (including ctDNA and metabolic panels) to elucidate mechanisms, assess the role of adiposity and insulin resistance, and identify the patient subgroups most likely to benefit,” he noted.

For now, GLP1 medications are an option in “eligible colon cancer patients with severe obesity or diabetes who meet standard metabolic indications,” Cuomo told this news organization.

Commenting on this study for this news organization, David Greenwald, MD, director of Clinical Gastroenterology and Endoscopy at Icahn School of Medicine at Mount Sinai Hospital in New York City, noted “other studies have showed a lower risk of developing colorectal cancer in the first place and then improved survival.”

Greenwald cited a recent study that found people with diabetes who took GLP-1 RAs had a 44% lower risk of developing colorectal cancer than those who took insulin, and a 25% lower risk than those who took metformin.

The effects of GLP-1s in colon cancer are “very intriguing and very promising but more research is needed to confirm whether this is really true and the mechanisms behind it,” said Greenwald.

In terms of the lowering risk of developing colorectal cancer, “probably first and foremost is that the drugs are really effective in promoting weight loss. And if you can reduce obesity in the population, you do all sorts of good things — reduce diabetes, reduce heart disease, and maybe reduce colorectal cancer,” Greenwald said.

This study had no specific funding. Cuomo and Greenwald had no relevant disclosures.

A version of this article first appeared on Medscape.com.

You are in the middle of a busy clinic day and think, “there has to be a better way to do this.” Suddenly, a better way to do something becomes obvious. Maybe it’s a tool that simplifies documentation, a device that improves patient comfort, or an app that bridges a clinical gap. Many physicians, especially early career gastroenterologists, have ideas like this, but few know what to do next.

This article is for the curious innovator at the beginning of their clinical career. It offers practical, real-world guidance on developing a clinical product: whether that be hardware, software, or a hybrid. It outlines what questions to ask, who to consult, and how to protect your work, using personal insights and business principles learned through lived experience.

1. Understand Intellectual Property (IP): Know Its Value and Ownership

What is IP?

Intellectual property refers to your original creations: inventions, designs, software, and more. This is what you want to protect legally through patents, trademarks, or copyrights.

Who owns your idea?

This is the first and most important question to ask. If you are employed (especially by a hospital or academic center), your contract may already give your employer rights to any inventions you create, even those developed in your personal time.

What to ask:

• Does my employment contract include an “assignment of inventions” clause?
• Does the institution claim rights to anything developed with institutional resources?
• Are there moonlighting or external activity policies that affect this?

If you are developing an idea on your personal time, with your own resources, and outside your scope of clinical duties, it might still be considered “theirs” under some contracts. Early legal consultation is critical. A specialized IP attorney can help you understand what you own and how to protect it. This should be done early, ideally before you start building anything. 
 

2. Lawyers Aren’t Optional: They’re Essential Early Partners

You do not need a full legal team, but you do need a lawyer early. An early consultation with an IP attorney can clarify your rights, guide your filing process (e.g. provisional patents), and help you avoid costly missteps.

Do this before sharing your idea publicly, including in academic presentations, pitch competitions, or even on social media. Public disclosure can start a clock ticking for application to protect your IP.
 

3. Build a Founding Team with Intent

Think of your startup team like a long-term relationship: you’re committing to build something together through uncertainty, tension, and change.

Strong early-stage teams often include:

• The Visionary – understands the clinical need and vision
• The Builder – engineer, developer, or designer
• The Doer – project manager or operations lead

Before forming a company, clearly define:

• Ownership (equity percentages)
• Roles and responsibilities
• Time commitments
• What happens if someone exits

Have these discussions early and document your agreements. Avoid informal “handshake” deals that can lead to serious disputes later.
 

4. You Don’t Need to Know Everything on Day One

You do not need to know how to write code, build a prototype, or get FDA clearance on day one. Successful innovators are humble learners. Use a Minimum Viable Product (MVP), a simple, functional version of your idea, to test assumptions and gather feedback. Iterate based on what you learn. Do not chase perfection; pursue progress. Consider using online accelerators like Y Combinator’s startup school or AGA’s Center for GI Innovation and Technology. 
 

5. Incubators: Use them Strategically

Incubators can offer mentorship, seed funding, legal support, and technical resources, but they vary widely in value (see Table 1). Many may want equity, and not all offer when you truly need. 


Ask Yourself:

• Do I need technical help, business mentorship, or just accountability?
• What does this incubator offer in terms of IP protection, exposure, and connections?
• Do I understand the equity trade-off?
• What services and funding do they provide?
• Do they take equity? How much and when?
• What’s their track record with similar ventures?
• Are their incentives aligned with your vision?
•  

6. Academic Institutions: Partners or Pitfalls?

Universities can provide credibility, resources, and early funding through their tech transfer office (TTO).


Key Questions to Ask:

• Will my IP be managed by the TTO?
• How much say do I have in licensing decisions?
• Are there royalty-sharing agreements in place?
• Can I form a startup while employed here?

You may need to negotiate if you want to commercialize your idea independently. 
 

7. Do it for Purpose, Not Payday

Most founders end up owning only a small percentage of their company by the time a product reaches the market. Do not expect to get rich. Do it because it solves a problem you care about. If it happens to come with a nice paycheck, then that is an added bonus.

Your clinical training and insight give you a unique edge. You already know what’s broken. Use that as your compass. 
 

Conclusion

Innovation isn’t about brilliance, it’s about curiosity, structure, and tenacity (see Table 2). Start small. Protect your work. Choose the right partners. Most importantly, stay anchored in your mission to make GI care better.

Dr. Muratore is based at UNC Rex Digestive Health, Raleigh, North Carolina. She has no conflicts related to this article. Dr. Wechsler is based at the University of North Carolina at Chapel Hill, Chapel Hill, North Carolina. She holds a patent assigned to Trustees of Dartmouth College. Dr. Shah is based at the University of Michigan, Ann Arbor, Michigan. He consults for Ardelyx, Laborie, Neuraxis, Salix, Sanofi, and Takeda and holds a patent with the Regents of the University of Michigan.

You are in the middle of a busy clinic day and think, “there has to be a better way to do this.” Suddenly, a better way to do something becomes obvious. Maybe it’s a tool that simplifies documentation, a device that improves patient comfort, or an app that bridges a clinical gap. Many physicians, especially early career gastroenterologists, have ideas like this, but few know what to do next.

This article is for the curious innovator at the beginning of their clinical career. It offers practical, real-world guidance on developing a clinical product: whether that be hardware, software, or a hybrid. It outlines what questions to ask, who to consult, and how to protect your work, using personal insights and business principles learned through lived experience.

1. Understand Intellectual Property (IP): Know Its Value and Ownership

What is IP?

Intellectual property refers to your original creations: inventions, designs, software, and more. This is what you want to protect legally through patents, trademarks, or copyrights.

Who owns your idea?

This is the first and most important question to ask. If you are employed (especially by a hospital or academic center), your contract may already give your employer rights to any inventions you create, even those developed in your personal time.

What to ask:

• Does my employment contract include an “assignment of inventions” clause?
• Does the institution claim rights to anything developed with institutional resources?
• Are there moonlighting or external activity policies that affect this?

If you are developing an idea on your personal time, with your own resources, and outside your scope of clinical duties, it might still be considered “theirs” under some contracts. Early legal consultation is critical. A specialized IP attorney can help you understand what you own and how to protect it. This should be done early, ideally before you start building anything. 
 

2. Lawyers Aren’t Optional: They’re Essential Early Partners

You do not need a full legal team, but you do need a lawyer early. An early consultation with an IP attorney can clarify your rights, guide your filing process (e.g. provisional patents), and help you avoid costly missteps.

Do this before sharing your idea publicly, including in academic presentations, pitch competitions, or even on social media. Public disclosure can start a clock ticking for application to protect your IP.
 

3. Build a Founding Team with Intent

Think of your startup team like a long-term relationship: you’re committing to build something together through uncertainty, tension, and change.

Strong early-stage teams often include:

• The Visionary – understands the clinical need and vision
• The Builder – engineer, developer, or designer
• The Doer – project manager or operations lead

Before forming a company, clearly define:

• Ownership (equity percentages)
• Roles and responsibilities
• Time commitments
• What happens if someone exits

Have these discussions early and document your agreements. Avoid informal “handshake” deals that can lead to serious disputes later.
 

4. You Don’t Need to Know Everything on Day One

You do not need to know how to write code, build a prototype, or get FDA clearance on day one. Successful innovators are humble learners. Use a Minimum Viable Product (MVP), a simple, functional version of your idea, to test assumptions and gather feedback. Iterate based on what you learn. Do not chase perfection; pursue progress. Consider using online accelerators like Y Combinator’s startup school or AGA’s Center for GI Innovation and Technology. 
 

5. Incubators: Use them Strategically

Incubators can offer mentorship, seed funding, legal support, and technical resources, but they vary widely in value (see Table 1). Many may want equity, and not all offer when you truly need. 


Ask Yourself:

• Do I need technical help, business mentorship, or just accountability?
• What does this incubator offer in terms of IP protection, exposure, and connections?
• Do I understand the equity trade-off?
• What services and funding do they provide?
• Do they take equity? How much and when?
• What’s their track record with similar ventures?
• Are their incentives aligned with your vision?
•  

6. Academic Institutions: Partners or Pitfalls?

Universities can provide credibility, resources, and early funding through their tech transfer office (TTO).


Key Questions to Ask:

• Will my IP be managed by the TTO?
• How much say do I have in licensing decisions?
• Are there royalty-sharing agreements in place?
• Can I form a startup while employed here?

You may need to negotiate if you want to commercialize your idea independently. 
 

7. Do it for Purpose, Not Payday

Most founders end up owning only a small percentage of their company by the time a product reaches the market. Do not expect to get rich. Do it because it solves a problem you care about. If it happens to come with a nice paycheck, then that is an added bonus.

Your clinical training and insight give you a unique edge. You already know what’s broken. Use that as your compass. 
 

Conclusion

Innovation isn’t about brilliance, it’s about curiosity, structure, and tenacity (see Table 2). Start small. Protect your work. Choose the right partners. Most importantly, stay anchored in your mission to make GI care better.

Dr. Muratore is based at UNC Rex Digestive Health, Raleigh, North Carolina. She has no conflicts related to this article. Dr. Wechsler is based at the University of North Carolina at Chapel Hill, Chapel Hill, North Carolina. She holds a patent assigned to Trustees of Dartmouth College. Dr. Shah is based at the University of Michigan, Ann Arbor, Michigan. He consults for Ardelyx, Laborie, Neuraxis, Salix, Sanofi, and Takeda and holds a patent with the Regents of the University of Michigan.

You are in the middle of a busy clinic day and think, “there has to be a better way to do this.” Suddenly, a better way to do something becomes obvious. Maybe it’s a tool that simplifies documentation, a device that improves patient comfort, or an app that bridges a clinical gap. Many physicians, especially early career gastroenterologists, have ideas like this, but few know what to do next.

This article is for the curious innovator at the beginning of their clinical career. It offers practical, real-world guidance on developing a clinical product: whether that be hardware, software, or a hybrid. It outlines what questions to ask, who to consult, and how to protect your work, using personal insights and business principles learned through lived experience.

1. Understand Intellectual Property (IP): Know Its Value and Ownership

What is IP?

Intellectual property refers to your original creations: inventions, designs, software, and more. This is what you want to protect legally through patents, trademarks, or copyrights.

Who owns your idea?

This is the first and most important question to ask. If you are employed (especially by a hospital or academic center), your contract may already give your employer rights to any inventions you create, even those developed in your personal time.

What to ask:

• Does my employment contract include an “assignment of inventions” clause?
• Does the institution claim rights to anything developed with institutional resources?
• Are there moonlighting or external activity policies that affect this?

If you are developing an idea on your personal time, with your own resources, and outside your scope of clinical duties, it might still be considered “theirs” under some contracts. Early legal consultation is critical. A specialized IP attorney can help you understand what you own and how to protect it. This should be done early, ideally before you start building anything. 
 

2. Lawyers Aren’t Optional: They’re Essential Early Partners

You do not need a full legal team, but you do need a lawyer early. An early consultation with an IP attorney can clarify your rights, guide your filing process (e.g. provisional patents), and help you avoid costly missteps.

Do this before sharing your idea publicly, including in academic presentations, pitch competitions, or even on social media. Public disclosure can start a clock ticking for application to protect your IP.
 

3. Build a Founding Team with Intent

Think of your startup team like a long-term relationship: you’re committing to build something together through uncertainty, tension, and change.

Strong early-stage teams often include:

• The Visionary – understands the clinical need and vision
• The Builder – engineer, developer, or designer
• The Doer – project manager or operations lead

Before forming a company, clearly define:

• Ownership (equity percentages)
• Roles and responsibilities
• Time commitments
• What happens if someone exits

Have these discussions early and document your agreements. Avoid informal “handshake” deals that can lead to serious disputes later.
 

4. You Don’t Need to Know Everything on Day One

You do not need to know how to write code, build a prototype, or get FDA clearance on day one. Successful innovators are humble learners. Use a Minimum Viable Product (MVP), a simple, functional version of your idea, to test assumptions and gather feedback. Iterate based on what you learn. Do not chase perfection; pursue progress. Consider using online accelerators like Y Combinator’s startup school or AGA’s Center for GI Innovation and Technology. 
 

5. Incubators: Use them Strategically

Incubators can offer mentorship, seed funding, legal support, and technical resources, but they vary widely in value (see Table 1). Many may want equity, and not all offer when you truly need. 


Ask Yourself:

• Do I need technical help, business mentorship, or just accountability?
• What does this incubator offer in terms of IP protection, exposure, and connections?
• Do I understand the equity trade-off?
• What services and funding do they provide?
• Do they take equity? How much and when?
• What’s their track record with similar ventures?
• Are their incentives aligned with your vision?
•  

6. Academic Institutions: Partners or Pitfalls?

Universities can provide credibility, resources, and early funding through their tech transfer office (TTO).


Key Questions to Ask:

• Will my IP be managed by the TTO?
• How much say do I have in licensing decisions?
• Are there royalty-sharing agreements in place?
• Can I form a startup while employed here?

You may need to negotiate if you want to commercialize your idea independently. 
 

7. Do it for Purpose, Not Payday

Most founders end up owning only a small percentage of their company by the time a product reaches the market. Do not expect to get rich. Do it because it solves a problem you care about. If it happens to come with a nice paycheck, then that is an added bonus.

Your clinical training and insight give you a unique edge. You already know what’s broken. Use that as your compass. 
 

Conclusion

Innovation isn’t about brilliance, it’s about curiosity, structure, and tenacity (see Table 2). Start small. Protect your work. Choose the right partners. Most importantly, stay anchored in your mission to make GI care better.

Dr. Muratore is based at UNC Rex Digestive Health, Raleigh, North Carolina. She has no conflicts related to this article. Dr. Wechsler is based at the University of North Carolina at Chapel Hill, Chapel Hill, North Carolina. She holds a patent assigned to Trustees of Dartmouth College. Dr. Shah is based at the University of Michigan, Ann Arbor, Michigan. He consults for Ardelyx, Laborie, Neuraxis, Salix, Sanofi, and Takeda and holds a patent with the Regents of the University of Michigan.

Introduction

For many of us in gastroenterology, landing that first attending job feels like the ultimate victory lap — the reward for all those years of training. We sign the contract, relocate, and imagine this will be our “forever job.” Reality often plays out differently.

In fact, 43% of physicians change jobs within five years, while 83% changed employers at least once in their careers.¹ Even within our field — which is always in demand — turnover is high; 1 in 3 gastroenterologists are planning to leave their current role within two years.² Why does this happen? More importantly, how do we navigate this transition with clarity and confidence as an early-career GI?
 

My Story: When I Dared to Change My “Forever Job”

When I signed my first attending contract, I didn’t negotiate a single thing. My priorities were simple: family in Toronto and visa requirements. After a decade of medical school, residency, and fellowship, everything else felt secondary. I was happy to be back home.

The job itself was good — reasonable hours, flexible colleagues, and ample opportunity to enhance my procedural skills. As I started carving out my niche in endobariatrics, the support I needed to grow further was not there. I kept telling myself that this job fulfilled my values and I needed to be patient: “this is my forever job. I am close to my family and that’s what matters.”

Then, during a suturing course at the American Society of Gastrointestinal Endoscopy, I had a casual chat with the course director (now my boss). It took me by surprise, but as the conversation continued, he offered me a job. It was tempting: the chance to build my own endobariatrics program with real institutional backing. The catch? It was in a city I had never been to, with no family or friends around. I politely said “no, thank you, I can’t.” He smiled, gave me his number, and said, “think about it.”

For the first time, I allowed myself to ask, “could I really leave my forever job?”
 

The Power of a Circle and a Spreadsheet

I leaned on my circle — a close group of fellowship friends who each took a turn being someone’s lifeline. We have monthly Zoom calls to talk about jobs, family, and career aspirations. When I shared my dilemma, I realized I wasn’t alone; one friend was also unhappy with her first job. Suddenly, we were asking one another, “can we really leave?”

I hired a career consultant familiar with physician visa issues — hands down, the best money I ever invested. The job search felt like dating: each interview was a first date; some needed a second or third date before I knew if it could be a match.

After every interview, I’d jump on Zoom with my circle. We’d screen-share my giant Excel spreadsheet — our decision matrix — with columns for everything I cared about:

• Institute
• Administrative Time
• Endobariatric support
• Director Title
• Salary
• On-call
• Vacation
• Proximity to airport
• Cost of living
• RVU percentage
• Endoscopy center buy-in
• Contract duration
• Support staff
• CME

We scored each job, line by line, and not a single job checked all the boxes. As I sat there in a state of decision paralysis, it became clear that this was not a simple decision.
 

The GI Community: A Small, Supportive World

The GI community is incredibly close-knit and kind-hearted. At every conference, I made a point to chat with as many colleagues as I could, to hear their perspectives on jobs and how they made tough career moves. Those conversations were real — no Google search or Excel sheet could offer the perspective and insight I gained by simply asking and leaning on the GI community.

Meanwhile, the person who had first offered me that job kept checking in, catching up at conferences, and bonding over our love for food and baking. With him, I never felt like I was being ‘interviewed’ — I felt valued. It did not feel like he was trying to fill a position with just anyone to improve the call pool. He genuinely wanted to understand what my goals were and how I envisioned my future. Through those conversations, he reminded me of my original passions, which were sidelined when so immersed in the daily routine. 

I’ve learned that feeling valued doesn’t come from grand gestures in recruitment. It’s in the quiet signs of respect, trust, and being seen. He wasn’t looking for just anyone; he was looking for someone whose goals aligned with his group’s and someone in whom he wanted to invest. While others might chase the highest salary, the most flexible schedule, or the strongest ancillary support, I realized I valued something I did not realize that I was lacking until then: mentorship.
 

What I Learned: There is No Such Thing As “The Perfect Job”

After a full year of spreadsheets, Zoom calls, conference chats, and overthinking, I came to a big realization: there’s no perfect job — there’s no such thing as an ideal “forever job.” The only constant for humans is change. Our circumstances change, our priorities shift, our interests shuffle, and our finances evolve. The best job is simply the one that fits the stage of life you’re in at that given moment. For me, mentorship and growth became my top priorities, even if it meant moving away from family.

What Physicians Value Most in a Second Job

After their first job, early-career gastroenterologists often reevaluate what really matters. Recent surveys highlight four key priorities:

• Work-life balance:

In a 2022 CompHealth Group healthcare survey, 85% of physicians ranked work-life balance as their top job priority.³

• Mentorship and growth:

Nearly 1 in 3 physicians cited lack of mentorship or career advancement as their reason for leaving a first job, per the 2023 MGMA/Jackson Physician Search report.⁴

• Compensation:

While not always the main reason for leaving, 77% of physicians now list compensation as a top priority — a big jump from prior years.³

• Practice support:

Poor infrastructure, administrative overload, or understaffed teams are common dealbreakers. In the second job, physicians look for well-run practices with solid support staff and reduced burnout risk.⁵

Conclusion

Your first job doesn’t have to be your last. What matters is knowing when it’s time to evolve. Welcome the uncertainty, talk to your circle, lean on your community, and use a spreadsheet if you need to — but don’t forget to trust your gut. There’s no forever job or the perfect path, only the next move that feels most true to who you are in that moment.

Dr. Ismail (@mayyismail) is Assistant Professor of Clinical Medicine (Gastroenterology) at Temple University in Philadelphia, Pennsylvania. She declares no conflicts of interest.

References

1. CHG Healthcare. Survey: 62% of physicians made a career change in the last two years. CHG Healthcare blog. June 10, 2024. Accessed August 5, 2025.


2. Berg S. Physicians in these 10 specialties are less likely to quit. AMA News. Published June 24, 2025. Accessed July 2025. 


3. Saley C. Survey: Work/life balance is #1 priority in physicians’ job search. CHG Healthcare Insights. March 10, 2022. Accessed August 2025. 


4. Medical Group Management Association; Jackson Physician Search. Early‑Career Physician Recruiting & Retention Playbook. October 23, 2023. Accessed August 2025. 


5. Von Rosenvinge EC, et al. A crisis in scope: Recruitment and retention challenges reported by VA gastroenterology section chiefs. Fed Pract. 2024 Aug. doi:10.12788/fp.0504.

Introduction

For many of us in gastroenterology, landing that first attending job feels like the ultimate victory lap — the reward for all those years of training. We sign the contract, relocate, and imagine this will be our “forever job.” Reality often plays out differently.

In fact, 43% of physicians change jobs within five years, while 83% changed employers at least once in their careers.¹ Even within our field — which is always in demand — turnover is high; 1 in 3 gastroenterologists are planning to leave their current role within two years.² Why does this happen? More importantly, how do we navigate this transition with clarity and confidence as an early-career GI?
 

My Story: When I Dared to Change My “Forever Job”

When I signed my first attending contract, I didn’t negotiate a single thing. My priorities were simple: family in Toronto and visa requirements. After a decade of medical school, residency, and fellowship, everything else felt secondary. I was happy to be back home.

The job itself was good — reasonable hours, flexible colleagues, and ample opportunity to enhance my procedural skills. As I started carving out my niche in endobariatrics, the support I needed to grow further was not there. I kept telling myself that this job fulfilled my values and I needed to be patient: “this is my forever job. I am close to my family and that’s what matters.”

Then, during a suturing course at the American Society of Gastrointestinal Endoscopy, I had a casual chat with the course director (now my boss). It took me by surprise, but as the conversation continued, he offered me a job. It was tempting: the chance to build my own endobariatrics program with real institutional backing. The catch? It was in a city I had never been to, with no family or friends around. I politely said “no, thank you, I can’t.” He smiled, gave me his number, and said, “think about it.”

For the first time, I allowed myself to ask, “could I really leave my forever job?”
 

The Power of a Circle and a Spreadsheet

I leaned on my circle — a close group of fellowship friends who each took a turn being someone’s lifeline. We have monthly Zoom calls to talk about jobs, family, and career aspirations. When I shared my dilemma, I realized I wasn’t alone; one friend was also unhappy with her first job. Suddenly, we were asking one another, “can we really leave?”

I hired a career consultant familiar with physician visa issues — hands down, the best money I ever invested. The job search felt like dating: each interview was a first date; some needed a second or third date before I knew if it could be a match.

After every interview, I’d jump on Zoom with my circle. We’d screen-share my giant Excel spreadsheet — our decision matrix — with columns for everything I cared about:

• Institute
• Administrative Time
• Endobariatric support
• Director Title
• Salary
• On-call
• Vacation
• Proximity to airport
• Cost of living
• RVU percentage
• Endoscopy center buy-in
• Contract duration
• Support staff
• CME

We scored each job, line by line, and not a single job checked all the boxes. As I sat there in a state of decision paralysis, it became clear that this was not a simple decision.
 

The GI Community: A Small, Supportive World

The GI community is incredibly close-knit and kind-hearted. At every conference, I made a point to chat with as many colleagues as I could, to hear their perspectives on jobs and how they made tough career moves. Those conversations were real — no Google search or Excel sheet could offer the perspective and insight I gained by simply asking and leaning on the GI community.

Meanwhile, the person who had first offered me that job kept checking in, catching up at conferences, and bonding over our love for food and baking. With him, I never felt like I was being ‘interviewed’ — I felt valued. It did not feel like he was trying to fill a position with just anyone to improve the call pool. He genuinely wanted to understand what my goals were and how I envisioned my future. Through those conversations, he reminded me of my original passions, which were sidelined when so immersed in the daily routine. 

I’ve learned that feeling valued doesn’t come from grand gestures in recruitment. It’s in the quiet signs of respect, trust, and being seen. He wasn’t looking for just anyone; he was looking for someone whose goals aligned with his group’s and someone in whom he wanted to invest. While others might chase the highest salary, the most flexible schedule, or the strongest ancillary support, I realized I valued something I did not realize that I was lacking until then: mentorship.
 

What I Learned: There is No Such Thing As “The Perfect Job”

After a full year of spreadsheets, Zoom calls, conference chats, and overthinking, I came to a big realization: there’s no perfect job — there’s no such thing as an ideal “forever job.” The only constant for humans is change. Our circumstances change, our priorities shift, our interests shuffle, and our finances evolve. The best job is simply the one that fits the stage of life you’re in at that given moment. For me, mentorship and growth became my top priorities, even if it meant moving away from family.

What Physicians Value Most in a Second Job

After their first job, early-career gastroenterologists often reevaluate what really matters. Recent surveys highlight four key priorities:

• Work-life balance:

In a 2022 CompHealth Group healthcare survey, 85% of physicians ranked work-life balance as their top job priority.³

• Mentorship and growth:

Nearly 1 in 3 physicians cited lack of mentorship or career advancement as their reason for leaving a first job, per the 2023 MGMA/Jackson Physician Search report.⁴

• Compensation:

While not always the main reason for leaving, 77% of physicians now list compensation as a top priority — a big jump from prior years.³

• Practice support:

Poor infrastructure, administrative overload, or understaffed teams are common dealbreakers. In the second job, physicians look for well-run practices with solid support staff and reduced burnout risk.⁵

Conclusion

Your first job doesn’t have to be your last. What matters is knowing when it’s time to evolve. Welcome the uncertainty, talk to your circle, lean on your community, and use a spreadsheet if you need to — but don’t forget to trust your gut. There’s no forever job or the perfect path, only the next move that feels most true to who you are in that moment.

Dr. Ismail (@mayyismail) is Assistant Professor of Clinical Medicine (Gastroenterology) at Temple University in Philadelphia, Pennsylvania. She declares no conflicts of interest.

References

1. CHG Healthcare. Survey: 62% of physicians made a career change in the last two years. CHG Healthcare blog. June 10, 2024. Accessed August 5, 2025.


2. Berg S. Physicians in these 10 specialties are less likely to quit. AMA News. Published June 24, 2025. Accessed July 2025. 


3. Saley C. Survey: Work/life balance is #1 priority in physicians’ job search. CHG Healthcare Insights. March 10, 2022. Accessed August 2025. 


4. Medical Group Management Association; Jackson Physician Search. Early‑Career Physician Recruiting & Retention Playbook. October 23, 2023. Accessed August 2025. 


5. Von Rosenvinge EC, et al. A crisis in scope: Recruitment and retention challenges reported by VA gastroenterology section chiefs. Fed Pract. 2024 Aug. doi:10.12788/fp.0504.

Introduction

For many of us in gastroenterology, landing that first attending job feels like the ultimate victory lap — the reward for all those years of training. We sign the contract, relocate, and imagine this will be our “forever job.” Reality often plays out differently.

In fact, 43% of physicians change jobs within five years, while 83% changed employers at least once in their careers.¹ Even within our field — which is always in demand — turnover is high; 1 in 3 gastroenterologists are planning to leave their current role within two years.² Why does this happen? More importantly, how do we navigate this transition with clarity and confidence as an early-career GI?
 

My Story: When I Dared to Change My “Forever Job”

When I signed my first attending contract, I didn’t negotiate a single thing. My priorities were simple: family in Toronto and visa requirements. After a decade of medical school, residency, and fellowship, everything else felt secondary. I was happy to be back home.

The job itself was good — reasonable hours, flexible colleagues, and ample opportunity to enhance my procedural skills. As I started carving out my niche in endobariatrics, the support I needed to grow further was not there. I kept telling myself that this job fulfilled my values and I needed to be patient: “this is my forever job. I am close to my family and that’s what matters.”

Then, during a suturing course at the American Society of Gastrointestinal Endoscopy, I had a casual chat with the course director (now my boss). It took me by surprise, but as the conversation continued, he offered me a job. It was tempting: the chance to build my own endobariatrics program with real institutional backing. The catch? It was in a city I had never been to, with no family or friends around. I politely said “no, thank you, I can’t.” He smiled, gave me his number, and said, “think about it.”

For the first time, I allowed myself to ask, “could I really leave my forever job?”
 

The Power of a Circle and a Spreadsheet

I leaned on my circle — a close group of fellowship friends who each took a turn being someone’s lifeline. We have monthly Zoom calls to talk about jobs, family, and career aspirations. When I shared my dilemma, I realized I wasn’t alone; one friend was also unhappy with her first job. Suddenly, we were asking one another, “can we really leave?”

I hired a career consultant familiar with physician visa issues — hands down, the best money I ever invested. The job search felt like dating: each interview was a first date; some needed a second or third date before I knew if it could be a match.

After every interview, I’d jump on Zoom with my circle. We’d screen-share my giant Excel spreadsheet — our decision matrix — with columns for everything I cared about:

• Institute
• Administrative Time
• Endobariatric support
• Director Title
• Salary
• On-call
• Vacation
• Proximity to airport
• Cost of living
• RVU percentage
• Endoscopy center buy-in
• Contract duration
• Support staff
• CME

We scored each job, line by line, and not a single job checked all the boxes. As I sat there in a state of decision paralysis, it became clear that this was not a simple decision.
 

The GI Community: A Small, Supportive World

The GI community is incredibly close-knit and kind-hearted. At every conference, I made a point to chat with as many colleagues as I could, to hear their perspectives on jobs and how they made tough career moves. Those conversations were real — no Google search or Excel sheet could offer the perspective and insight I gained by simply asking and leaning on the GI community.

Meanwhile, the person who had first offered me that job kept checking in, catching up at conferences, and bonding over our love for food and baking. With him, I never felt like I was being ‘interviewed’ — I felt valued. It did not feel like he was trying to fill a position with just anyone to improve the call pool. He genuinely wanted to understand what my goals were and how I envisioned my future. Through those conversations, he reminded me of my original passions, which were sidelined when so immersed in the daily routine. 

I’ve learned that feeling valued doesn’t come from grand gestures in recruitment. It’s in the quiet signs of respect, trust, and being seen. He wasn’t looking for just anyone; he was looking for someone whose goals aligned with his group’s and someone in whom he wanted to invest. While others might chase the highest salary, the most flexible schedule, or the strongest ancillary support, I realized I valued something I did not realize that I was lacking until then: mentorship.
 

What I Learned: There is No Such Thing As “The Perfect Job”

After a full year of spreadsheets, Zoom calls, conference chats, and overthinking, I came to a big realization: there’s no perfect job — there’s no such thing as an ideal “forever job.” The only constant for humans is change. Our circumstances change, our priorities shift, our interests shuffle, and our finances evolve. The best job is simply the one that fits the stage of life you’re in at that given moment. For me, mentorship and growth became my top priorities, even if it meant moving away from family.

What Physicians Value Most in a Second Job

After their first job, early-career gastroenterologists often reevaluate what really matters. Recent surveys highlight four key priorities:

• Work-life balance:

In a 2022 CompHealth Group healthcare survey, 85% of physicians ranked work-life balance as their top job priority.³

• Mentorship and growth:

Nearly 1 in 3 physicians cited lack of mentorship or career advancement as their reason for leaving a first job, per the 2023 MGMA/Jackson Physician Search report.⁴

• Compensation:

While not always the main reason for leaving, 77% of physicians now list compensation as a top priority — a big jump from prior years.³

• Practice support:

Poor infrastructure, administrative overload, or understaffed teams are common dealbreakers. In the second job, physicians look for well-run practices with solid support staff and reduced burnout risk.⁵

Conclusion

Your first job doesn’t have to be your last. What matters is knowing when it’s time to evolve. Welcome the uncertainty, talk to your circle, lean on your community, and use a spreadsheet if you need to — but don’t forget to trust your gut. There’s no forever job or the perfect path, only the next move that feels most true to who you are in that moment.

Dr. Ismail (@mayyismail) is Assistant Professor of Clinical Medicine (Gastroenterology) at Temple University in Philadelphia, Pennsylvania. She declares no conflicts of interest.

References

1. CHG Healthcare. Survey: 62% of physicians made a career change in the last two years. CHG Healthcare blog. June 10, 2024. Accessed August 5, 2025.


2. Berg S. Physicians in these 10 specialties are less likely to quit. AMA News. Published June 24, 2025. Accessed July 2025. 


3. Saley C. Survey: Work/life balance is #1 priority in physicians’ job search. CHG Healthcare Insights. March 10, 2022. Accessed August 2025. 


4. Medical Group Management Association; Jackson Physician Search. Early‑Career Physician Recruiting & Retention Playbook. October 23, 2023. Accessed August 2025. 


5. Von Rosenvinge EC, et al. A crisis in scope: Recruitment and retention challenges reported by VA gastroenterology section chiefs. Fed Pract. 2024 Aug. doi:10.12788/fp.0504.

TOPLINE: 

Electronic health records patient portal signup rates were lower among vulnerable oncology patients at 64%, compared with 87% in nonvulnerable patients. Once adopted, both groups showed comparable meaningful use patterns. Non-English language emerged as a significant barrier to initial portal signup.

METHODOLOGY:

• Portal usage disparities persist across age, race, ethnicity, and health literacy groups, particularly at the initial signup stage.
• Oral anticancer medications represent a new frontier in cancer therapy, offering convenience but requiring high medication adherence and vigilant self-monitoring of symptoms.
• Researchers conducted a retrospective analysis of 280 patients who had recently started taking an oral anticancer medication at Tufts Medical Center, Boston, between October 2022 and March 2024.
• Vulnerability criteria included having an age ≥ 75 years, a non-English language preference, or subsidized insurance (Medicaid only or Medicare with Medicaid as secondary insurance).
• Analysis defined active portal use as having at least one message, while meaningful use was characterized by patient-provider bidirectional messaging.
• Portal messaging proxy use was determined through message content screening, particularly when non-English speaking patients sent messages in English or when message content indicated proxy use.

TAKEAWAY:

• Among the study population, 56% met vulnerability criteria, with 20% aged at least 75 years, 26% having a non-English language, and 30% having subsidized insurance.
• Non-English language was associated with lower portal signup rates (odds ratio [OR], 0.27; 95% CI, 0.15-0.49; P < .0001), whereas age and insurance status showed no significant association.
• Proxy messaging was utilized by 17% of vulnerable patients who signed up for the portal compared to 2.8% of nonvulnerable patients.
• Among patients who signed up for the portal, 31% used it specifically for communication about oral anticancer medications.

IN PRACTICE:

“Although patient portal signup was lower among vulnerable patients, once adopted, vulnerable patients demonstrated comparable meaningful use and greater proxy engagement. Fostering patient portal adoption requires a targeted approach with patient navigation and patient proxy engagement,” wrote the authors of the study.

SOURCE:

The study was led by Yenong Cao, MD, PhD, Boston Medical Center, Boston. It was published online on November 19 in JCO Oncology Practice.

LIMITATIONS:

The study was limited by its retrospective single-center design at Tufts Medical Center, which serves a large number of non-English, Chinese-speaking patients, potentially affecting the generalizability of findings. Additionally, formal proxy login identification was lacking in the Epic documentation during the study period, which may have led to underestimation of proxy portal use.

DISCLOSURES:

Cao reported being employed at Tufts Medical Center. Johnson Ching, PharmD, CSP, disclosed being employed at Duke University Hospital and SpeciaRx, LLC. Additional disclosures are noted in the original article. 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article first appeared on Medscape.com.

TOPLINE: 

Electronic health records patient portal signup rates were lower among vulnerable oncology patients at 64%, compared with 87% in nonvulnerable patients. Once adopted, both groups showed comparable meaningful use patterns. Non-English language emerged as a significant barrier to initial portal signup.

METHODOLOGY:

• Portal usage disparities persist across age, race, ethnicity, and health literacy groups, particularly at the initial signup stage.
• Oral anticancer medications represent a new frontier in cancer therapy, offering convenience but requiring high medication adherence and vigilant self-monitoring of symptoms.
• Researchers conducted a retrospective analysis of 280 patients who had recently started taking an oral anticancer medication at Tufts Medical Center, Boston, between October 2022 and March 2024.
• Vulnerability criteria included having an age ≥ 75 years, a non-English language preference, or subsidized insurance (Medicaid only or Medicare with Medicaid as secondary insurance).
• Analysis defined active portal use as having at least one message, while meaningful use was characterized by patient-provider bidirectional messaging.
• Portal messaging proxy use was determined through message content screening, particularly when non-English speaking patients sent messages in English or when message content indicated proxy use.

TAKEAWAY:

• Among the study population, 56% met vulnerability criteria, with 20% aged at least 75 years, 26% having a non-English language, and 30% having subsidized insurance.
• Non-English language was associated with lower portal signup rates (odds ratio [OR], 0.27; 95% CI, 0.15-0.49; P < .0001), whereas age and insurance status showed no significant association.
• Proxy messaging was utilized by 17% of vulnerable patients who signed up for the portal compared to 2.8% of nonvulnerable patients.
• Among patients who signed up for the portal, 31% used it specifically for communication about oral anticancer medications.

IN PRACTICE:

“Although patient portal signup was lower among vulnerable patients, once adopted, vulnerable patients demonstrated comparable meaningful use and greater proxy engagement. Fostering patient portal adoption requires a targeted approach with patient navigation and patient proxy engagement,” wrote the authors of the study.

SOURCE:

The study was led by Yenong Cao, MD, PhD, Boston Medical Center, Boston. It was published online on November 19 in JCO Oncology Practice.

LIMITATIONS:

The study was limited by its retrospective single-center design at Tufts Medical Center, which serves a large number of non-English, Chinese-speaking patients, potentially affecting the generalizability of findings. Additionally, formal proxy login identification was lacking in the Epic documentation during the study period, which may have led to underestimation of proxy portal use.

DISCLOSURES:

Cao reported being employed at Tufts Medical Center. Johnson Ching, PharmD, CSP, disclosed being employed at Duke University Hospital and SpeciaRx, LLC. Additional disclosures are noted in the original article. 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article first appeared on Medscape.com.

TOPLINE: 

Electronic health records patient portal signup rates were lower among vulnerable oncology patients at 64%, compared with 87% in nonvulnerable patients. Once adopted, both groups showed comparable meaningful use patterns. Non-English language emerged as a significant barrier to initial portal signup.

METHODOLOGY:

• Portal usage disparities persist across age, race, ethnicity, and health literacy groups, particularly at the initial signup stage.
• Oral anticancer medications represent a new frontier in cancer therapy, offering convenience but requiring high medication adherence and vigilant self-monitoring of symptoms.
• Researchers conducted a retrospective analysis of 280 patients who had recently started taking an oral anticancer medication at Tufts Medical Center, Boston, between October 2022 and March 2024.
• Vulnerability criteria included having an age ≥ 75 years, a non-English language preference, or subsidized insurance (Medicaid only or Medicare with Medicaid as secondary insurance).
• Analysis defined active portal use as having at least one message, while meaningful use was characterized by patient-provider bidirectional messaging.
• Portal messaging proxy use was determined through message content screening, particularly when non-English speaking patients sent messages in English or when message content indicated proxy use.

TAKEAWAY:

• Among the study population, 56% met vulnerability criteria, with 20% aged at least 75 years, 26% having a non-English language, and 30% having subsidized insurance.
• Non-English language was associated with lower portal signup rates (odds ratio [OR], 0.27; 95% CI, 0.15-0.49; P < .0001), whereas age and insurance status showed no significant association.
• Proxy messaging was utilized by 17% of vulnerable patients who signed up for the portal compared to 2.8% of nonvulnerable patients.
• Among patients who signed up for the portal, 31% used it specifically for communication about oral anticancer medications.

IN PRACTICE:

“Although patient portal signup was lower among vulnerable patients, once adopted, vulnerable patients demonstrated comparable meaningful use and greater proxy engagement. Fostering patient portal adoption requires a targeted approach with patient navigation and patient proxy engagement,” wrote the authors of the study.

SOURCE:

The study was led by Yenong Cao, MD, PhD, Boston Medical Center, Boston. It was published online on November 19 in JCO Oncology Practice.

LIMITATIONS:

The study was limited by its retrospective single-center design at Tufts Medical Center, which serves a large number of non-English, Chinese-speaking patients, potentially affecting the generalizability of findings. Additionally, formal proxy login identification was lacking in the Epic documentation during the study period, which may have led to underestimation of proxy portal use.

DISCLOSURES:

Cao reported being employed at Tufts Medical Center. Johnson Ching, PharmD, CSP, disclosed being employed at Duke University Hospital and SpeciaRx, LLC. Additional disclosures are noted in the original article. 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article first appeared on Medscape.com.

Jerome Winegarden, MD, had bad news to deliver. A patient’s cancer was progressing, and the patient would need to stop his oral cancer medication. 

That would normally mean tossing a 30-day supply of pills, said Winegarden, an oncologist with Trinity Health, a statewide health system in Michigan.

But not in this case. 

Winegarden pointed to a sign on his exam room wall from YesRx, a nonprofit cancer drug repository program, that read: “Thank you, Michiganders! Donating cancer medication and supportive medication helps patients in Michigan.”

When Winegarden suggested donating the pills to YesRx, the patient was grateful. Turning a bad situation into hope for somebody else is “very powerful for patients,” Winegarden said. “We were going to be able to do something with [the medication], not just destroy it.”

In just 2 years of operation, YesRx has accepted donations and provided oral cancer or supportive care medications worth millions of dollars to nearly 1200 patients, at no cost to them, according to a recent analysis assessing the Michigan-based program. These patients couldn’t afford their prescribed medications or required immediate access and couldn’t wait for insurance approval, the researchers reported. The donated unopened or unused medications would otherwise have been wasted.

“This program is exactly what patients need: a safe way of recycling their unused prescriptions that actually benefits others with cancer,” said Fumiko Chino, MD, associate professor at MD Anderson Cancer Center, Houston, Texas, in a statement on YesRx.
 

Filling a Need

A growing body of research shows that patients with cancer face an increased risk for financial toxicity, given the high costs of oral cancer drugs as well as changes to insurance coverage that may require greater cost sharing by the patient. The financial burden on patients can be significant, with more than half reporting trouble affording their medications, an issue that can lead to persistent medical debt as well as gaps or delays in care that may impact patient outcomes. 

Alongside the affordability problem is one of waste. A 2023 analysis found that the mean cost of drug waste associated with dose reductions or discontinuations of oral anticancer drugs came to $4290 per patient. 

The YesRx program, however, turns that negative into a positive.

If YesRx has a relevant drug in stock, “we can get the medication into the patient’s hands within 24-to-48 hours,” said Maja Gibbons, PharmD, an oncology pharmacy specialist with Corewell Health in Grand Rapids, Michigan.

Facilitating quick access is one key goal of the program, said YesRx co-founder and chief medical officer Emily Mackler, PharmD, who led the recent analysis. “All the things we’re trying to do are to make sure that the patient doesn’t experience those gaps that can really be critical for their outcomes,” Mackler this news organization. 

The drug repository concept has been around for decades. While there is no federal program, 29 states have general drug repository programs, according to the National Conference of State Legislatures. 

One of the oldest repositories, Iowa’s SafeNetRx, which started in 2001, reports that it has given free medications worth $155 million to almost 161,000 patients. SafeNetRx also began a partnership with state cancer centers to boost oral anticancer drug donations. From 2016 to 2022, the repository donated 84,000 chemotherapy doses worth $15 million to patients in need, reported Natalie K. Heater and colleagues at Northwestern University in Health Affairs Scholar.

In addition to Iowa, four other states have cancer drug repositories: Florida, Montana, Nebraska, and Michigan.

Michigan enacted a drug repository law in 2006, but YesRx did not start until 2023. The Michigan Oncology Quality Consortium, Blue Cross Blue Shield of Michigan, Trinity Health, and the Michigan Society of Hematology and Oncology provided funding to get YesRx off the ground. YesRx, which grew from nine sites in 2023 to 105 in July 2025, helps new sites get certified as a repository by the state. 

The program accepts donations of any room-temperature oral cancer or supportive care medication that is in its original, sealed manufacturer packaging and has at least 6 months before it expires. Controlled substances are not eligible, but medications such as anticoagulants and antiemetics are. Donations are sent by overnight delivery to Trinity Pharmacy at Reichert Health. Trinity receives and inspects donations, and redispenses medications for all YesRx participants. 

Nearly 1600 people have donated oral cancer medications, valued at $28.6 million, according to the 2-year look at the program. “I am blown away by how many donations come in,” Mackler this news organization.

In the first 24 months, 1171 patients received, on average, a 1-month supply of a medication worth $18.4 million, at no cost. Slightly more than half (53%) were age 65 or older. The most common diagnoses among recipients were breast cancer (28%), leukemia (18%), lung cancer (12%), and prostate cancer (9%). 

A survey about the program revealed that recipients spanned about 90% of Michigan counties, with around 40% living in rural areas. Survey respondents highlighted the value of YesRx, with most saying it was easy to use and that they could not have provided this assistance without support from the program. 

“YesRx can kind of swoop in,” said Winegarden. When a new prescription presents an issue for a patient, Winegarden checks if YesRx has a 30-day supply of the drug. If it does, patients “can get started on their treatment while we figure out the financial piece of it.”

Gibbons connects with patients in need through oncologists and financial navigators, as well as education sessions she runs for patients starting treatment. The Corewell location in Grand Rapids also holds “YesRx Donation Days,” when patients and caregivers can drop off medications. 

In just over a year, Corewell has provided “more than half a million dollars’ worth of medication to our cancer patients,” she said. “It’s just a large relief for patients to know that this is going to be able to help someone else out,” said Gibbons. 

Many of the cancer drugs “can be challenging for patients to get rid of,” Gibbons said. YesRx “is helping make sure that these medications don’t end up in things like landfills and water systems where they should not be.”

Mackler says she has big plans for expanding access. Next on the agenda is to enlist more practices in rural areas, especially in Michigan’s Upper Peninsula.

“We want to be accessible to anyone in the state with cancer,” said Mackler. “We would love to be able to help other states get to this point as well.”

Winegarden and Gibbons have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Jerome Winegarden, MD, had bad news to deliver. A patient’s cancer was progressing, and the patient would need to stop his oral cancer medication. 

That would normally mean tossing a 30-day supply of pills, said Winegarden, an oncologist with Trinity Health, a statewide health system in Michigan.

But not in this case. 

Winegarden pointed to a sign on his exam room wall from YesRx, a nonprofit cancer drug repository program, that read: “Thank you, Michiganders! Donating cancer medication and supportive medication helps patients in Michigan.”

When Winegarden suggested donating the pills to YesRx, the patient was grateful. Turning a bad situation into hope for somebody else is “very powerful for patients,” Winegarden said. “We were going to be able to do something with [the medication], not just destroy it.”

In just 2 years of operation, YesRx has accepted donations and provided oral cancer or supportive care medications worth millions of dollars to nearly 1200 patients, at no cost to them, according to a recent analysis assessing the Michigan-based program. These patients couldn’t afford their prescribed medications or required immediate access and couldn’t wait for insurance approval, the researchers reported. The donated unopened or unused medications would otherwise have been wasted.

“This program is exactly what patients need: a safe way of recycling their unused prescriptions that actually benefits others with cancer,” said Fumiko Chino, MD, associate professor at MD Anderson Cancer Center, Houston, Texas, in a statement on YesRx.
 

Filling a Need

A growing body of research shows that patients with cancer face an increased risk for financial toxicity, given the high costs of oral cancer drugs as well as changes to insurance coverage that may require greater cost sharing by the patient. The financial burden on patients can be significant, with more than half reporting trouble affording their medications, an issue that can lead to persistent medical debt as well as gaps or delays in care that may impact patient outcomes. 

Alongside the affordability problem is one of waste. A 2023 analysis found that the mean cost of drug waste associated with dose reductions or discontinuations of oral anticancer drugs came to $4290 per patient. 

The YesRx program, however, turns that negative into a positive.

If YesRx has a relevant drug in stock, “we can get the medication into the patient’s hands within 24-to-48 hours,” said Maja Gibbons, PharmD, an oncology pharmacy specialist with Corewell Health in Grand Rapids, Michigan.

Facilitating quick access is one key goal of the program, said YesRx co-founder and chief medical officer Emily Mackler, PharmD, who led the recent analysis. “All the things we’re trying to do are to make sure that the patient doesn’t experience those gaps that can really be critical for their outcomes,” Mackler this news organization. 

The drug repository concept has been around for decades. While there is no federal program, 29 states have general drug repository programs, according to the National Conference of State Legislatures. 

One of the oldest repositories, Iowa’s SafeNetRx, which started in 2001, reports that it has given free medications worth $155 million to almost 161,000 patients. SafeNetRx also began a partnership with state cancer centers to boost oral anticancer drug donations. From 2016 to 2022, the repository donated 84,000 chemotherapy doses worth $15 million to patients in need, reported Natalie K. Heater and colleagues at Northwestern University in Health Affairs Scholar.

In addition to Iowa, four other states have cancer drug repositories: Florida, Montana, Nebraska, and Michigan.

Michigan enacted a drug repository law in 2006, but YesRx did not start until 2023. The Michigan Oncology Quality Consortium, Blue Cross Blue Shield of Michigan, Trinity Health, and the Michigan Society of Hematology and Oncology provided funding to get YesRx off the ground. YesRx, which grew from nine sites in 2023 to 105 in July 2025, helps new sites get certified as a repository by the state. 

The program accepts donations of any room-temperature oral cancer or supportive care medication that is in its original, sealed manufacturer packaging and has at least 6 months before it expires. Controlled substances are not eligible, but medications such as anticoagulants and antiemetics are. Donations are sent by overnight delivery to Trinity Pharmacy at Reichert Health. Trinity receives and inspects donations, and redispenses medications for all YesRx participants. 

Nearly 1600 people have donated oral cancer medications, valued at $28.6 million, according to the 2-year look at the program. “I am blown away by how many donations come in,” Mackler this news organization.

In the first 24 months, 1171 patients received, on average, a 1-month supply of a medication worth $18.4 million, at no cost. Slightly more than half (53%) were age 65 or older. The most common diagnoses among recipients were breast cancer (28%), leukemia (18%), lung cancer (12%), and prostate cancer (9%). 

A survey about the program revealed that recipients spanned about 90% of Michigan counties, with around 40% living in rural areas. Survey respondents highlighted the value of YesRx, with most saying it was easy to use and that they could not have provided this assistance without support from the program. 

“YesRx can kind of swoop in,” said Winegarden. When a new prescription presents an issue for a patient, Winegarden checks if YesRx has a 30-day supply of the drug. If it does, patients “can get started on their treatment while we figure out the financial piece of it.”

Gibbons connects with patients in need through oncologists and financial navigators, as well as education sessions she runs for patients starting treatment. The Corewell location in Grand Rapids also holds “YesRx Donation Days,” when patients and caregivers can drop off medications. 

In just over a year, Corewell has provided “more than half a million dollars’ worth of medication to our cancer patients,” she said. “It’s just a large relief for patients to know that this is going to be able to help someone else out,” said Gibbons. 

Many of the cancer drugs “can be challenging for patients to get rid of,” Gibbons said. YesRx “is helping make sure that these medications don’t end up in things like landfills and water systems where they should not be.”

Mackler says she has big plans for expanding access. Next on the agenda is to enlist more practices in rural areas, especially in Michigan’s Upper Peninsula.

“We want to be accessible to anyone in the state with cancer,” said Mackler. “We would love to be able to help other states get to this point as well.”

Winegarden and Gibbons have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Jerome Winegarden, MD, had bad news to deliver. A patient’s cancer was progressing, and the patient would need to stop his oral cancer medication. 

That would normally mean tossing a 30-day supply of pills, said Winegarden, an oncologist with Trinity Health, a statewide health system in Michigan.

But not in this case. 

Winegarden pointed to a sign on his exam room wall from YesRx, a nonprofit cancer drug repository program, that read: “Thank you, Michiganders! Donating cancer medication and supportive medication helps patients in Michigan.”

When Winegarden suggested donating the pills to YesRx, the patient was grateful. Turning a bad situation into hope for somebody else is “very powerful for patients,” Winegarden said. “We were going to be able to do something with [the medication], not just destroy it.”

In just 2 years of operation, YesRx has accepted donations and provided oral cancer or supportive care medications worth millions of dollars to nearly 1200 patients, at no cost to them, according to a recent analysis assessing the Michigan-based program. These patients couldn’t afford their prescribed medications or required immediate access and couldn’t wait for insurance approval, the researchers reported. The donated unopened or unused medications would otherwise have been wasted.

“This program is exactly what patients need: a safe way of recycling their unused prescriptions that actually benefits others with cancer,” said Fumiko Chino, MD, associate professor at MD Anderson Cancer Center, Houston, Texas, in a statement on YesRx.
 

Filling a Need

A growing body of research shows that patients with cancer face an increased risk for financial toxicity, given the high costs of oral cancer drugs as well as changes to insurance coverage that may require greater cost sharing by the patient. The financial burden on patients can be significant, with more than half reporting trouble affording their medications, an issue that can lead to persistent medical debt as well as gaps or delays in care that may impact patient outcomes. 

Alongside the affordability problem is one of waste. A 2023 analysis found that the mean cost of drug waste associated with dose reductions or discontinuations of oral anticancer drugs came to $4290 per patient. 

The YesRx program, however, turns that negative into a positive.

If YesRx has a relevant drug in stock, “we can get the medication into the patient’s hands within 24-to-48 hours,” said Maja Gibbons, PharmD, an oncology pharmacy specialist with Corewell Health in Grand Rapids, Michigan.

Facilitating quick access is one key goal of the program, said YesRx co-founder and chief medical officer Emily Mackler, PharmD, who led the recent analysis. “All the things we’re trying to do are to make sure that the patient doesn’t experience those gaps that can really be critical for their outcomes,” Mackler this news organization. 

The drug repository concept has been around for decades. While there is no federal program, 29 states have general drug repository programs, according to the National Conference of State Legislatures. 

One of the oldest repositories, Iowa’s SafeNetRx, which started in 2001, reports that it has given free medications worth $155 million to almost 161,000 patients. SafeNetRx also began a partnership with state cancer centers to boost oral anticancer drug donations. From 2016 to 2022, the repository donated 84,000 chemotherapy doses worth $15 million to patients in need, reported Natalie K. Heater and colleagues at Northwestern University in Health Affairs Scholar.

In addition to Iowa, four other states have cancer drug repositories: Florida, Montana, Nebraska, and Michigan.

Michigan enacted a drug repository law in 2006, but YesRx did not start until 2023. The Michigan Oncology Quality Consortium, Blue Cross Blue Shield of Michigan, Trinity Health, and the Michigan Society of Hematology and Oncology provided funding to get YesRx off the ground. YesRx, which grew from nine sites in 2023 to 105 in July 2025, helps new sites get certified as a repository by the state. 

The program accepts donations of any room-temperature oral cancer or supportive care medication that is in its original, sealed manufacturer packaging and has at least 6 months before it expires. Controlled substances are not eligible, but medications such as anticoagulants and antiemetics are. Donations are sent by overnight delivery to Trinity Pharmacy at Reichert Health. Trinity receives and inspects donations, and redispenses medications for all YesRx participants. 

Nearly 1600 people have donated oral cancer medications, valued at $28.6 million, according to the 2-year look at the program. “I am blown away by how many donations come in,” Mackler this news organization.

In the first 24 months, 1171 patients received, on average, a 1-month supply of a medication worth $18.4 million, at no cost. Slightly more than half (53%) were age 65 or older. The most common diagnoses among recipients were breast cancer (28%), leukemia (18%), lung cancer (12%), and prostate cancer (9%). 

A survey about the program revealed that recipients spanned about 90% of Michigan counties, with around 40% living in rural areas. Survey respondents highlighted the value of YesRx, with most saying it was easy to use and that they could not have provided this assistance without support from the program. 

“YesRx can kind of swoop in,” said Winegarden. When a new prescription presents an issue for a patient, Winegarden checks if YesRx has a 30-day supply of the drug. If it does, patients “can get started on their treatment while we figure out the financial piece of it.”

Gibbons connects with patients in need through oncologists and financial navigators, as well as education sessions she runs for patients starting treatment. The Corewell location in Grand Rapids also holds “YesRx Donation Days,” when patients and caregivers can drop off medications. 

In just over a year, Corewell has provided “more than half a million dollars’ worth of medication to our cancer patients,” she said. “It’s just a large relief for patients to know that this is going to be able to help someone else out,” said Gibbons. 

Many of the cancer drugs “can be challenging for patients to get rid of,” Gibbons said. YesRx “is helping make sure that these medications don’t end up in things like landfills and water systems where they should not be.”

Mackler says she has big plans for expanding access. Next on the agenda is to enlist more practices in rural areas, especially in Michigan’s Upper Peninsula.

“We want to be accessible to anyone in the state with cancer,” said Mackler. “We would love to be able to help other states get to this point as well.”

Winegarden and Gibbons have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Beth Cavanaugh, 79, was starting a new medication when she ran into a modern hurdle: Her doctor’s office required all follow–up questions, even those about side effects of the drug, to go through the patient portal.

Cavanaugh said she did not know how to set up or use the system.

“I tried to explain that, but the receptionist said that was the only way to contact the doctor. I felt lost,” said Cavanaugh, a retired psychotherapist near Albany, New York.

Cavanaugh is far from alone. Many older people balk at the idea of communicating with their physicians over the internet. They may have limited digital skills, have physical challenges, or simply prefer human connection.

As medicine leans harder on electronic portals and telehealth, these patients are finding themselves shut out of their own care. Experts warn this approach deepens inequities in access to care and can worsen health outcomes.

Clinicians should “offer options for various types of communication, such as phone calls or texts, because whenever an older adult — or anyone, for that matter — is given a choice, they feel more empowered and more committed to their care,” said Susan Wehry, MD, associate clinical professor at the University of New England College of Osteopathic Medicine in Biddeford, Maine.
 

Tech Support

Use of medical communication tools varies among older adults. One study in JAMA Network Open found nearly two thirds of those older than 65 years who filled out surveys via phone or internet had used a patient portal, while a little under half used telehealth, and only 44% used a medical health application.

Older patients tend to fall into two camps, said Neela Patel, MD, MPH, CMD, chief of the Division of Geriatrics and Supportive Care at the UT Health San Antonio.

Her patients “are at two extremes of the spectrum — some technologically savvy and others with limited digital literacy or limited or no access to the Internet,” Patel, who is also the vice chair of the Health Systems Innovations and Technology Committee of the American Geriatric Society, said.

Patel’s practice has dedicated staff to help patients master certain technologies. For example, a pharmacist teaches patients how to use a glucometer and a blood pressure cuff. Other staff teach them how to use smartphone apps that track blood pressure or glucose.

She usually sees patients in person before offering telehealth as an option, ensuring the person has “enough digital literacy to utilize them and that the patient can see and hear the visit.”

If technological limitations impede a telehealth appointment, clinicians can help patients navigate their computer screen. Patel recounted the story of an older woman who was unable to come to the clinic in person, so had a telehealth visit instead.

“She had trouble hearing me, so I asked her to share her screen with me. I walked her through how to do that. Then I showed her where the ‘volume’ button was located. It turns out her volume was at zero,” Patel said. “Once that was adjusted, we were able to proceed with the appointment.”

Educating older adults on how to use health technology does not have to fall upon clinicians and their staff, according to Wehry. She routinely refers her patients to community resources to help them develop digital skills.

Local libraries and community centers often offer digital education. Some retirement communities and assisted living facilities also have tech support personnel or classes available to residents.

Wehry refers some of her patients to the National Digital Equity Center which teaches older adults how to hold a telehealth visit.

Roughly 90% of Patel’s patients are signed up for the patient portal, but they may not be operating the technology, she said. She advises these patients to ask their children or caregivers for help as appropriate. 

Teaching patients to use the communication technology early on can also be helpful in other ways. If patients who have been technologically proficient start having difficulty, “it’s a clue there may be cognitive changes, and we follow up on those,” Patel said.

Additional resources to help older adults develop digital competence include Cyber Seniors, Older Adults Technology Services, AARP, AARP Find Digital Courses, Area Agencies on Aging, and Senior Navigator.
 

Human Touch

Some older adults may simply want a more traditional means of communicating with their clinician. A review of 29 papers, encompassing over 6200 adults older than 60 years, identified several domains affecting the adoption of healthcare technology, two of which were resistance to new technology and having family or friends that could help with.

Wehry said many older adults “don’t resist this technology because they’re unable to figure out how to use it. Instead, they see the technology as too impersonal.”

One study found many older adults fear technologies may end up replacing face-to-face contact.

“I’m beginning to encourage primary care providers to take a step back and refocus on the doctor-patient relationship. When communication is limited to the technological approach, it can erode trust in that relationship,” Wehry said.

The American Medical Association recommends clinicians “provide a method other than electronic communication for patients who are without technological proficiency or access.”

Some busy clinicians might be concerned phone calls will be too time-consuming, Wehry said. Patients should be informed of hours of phone availability, how much time is allotted to calls, and how many days or hours a response may take. Clinicians might also use tools that allow patients to use their cell phone to text their practice with medical questions.

Cavanaugh ended up finding technological help from a professional organizer whom she hired to help rearrange her closets.

“She’s knowledgeable and patient, and she’s helping me with the portal,” she said. “If I hadn’t serendipitously found the organizer, I’d still be struggling and unable to access proper medical care.”

Wehry and Patel disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Beth Cavanaugh, 79, was starting a new medication when she ran into a modern hurdle: Her doctor’s office required all follow–up questions, even those about side effects of the drug, to go through the patient portal.

Cavanaugh said she did not know how to set up or use the system.

“I tried to explain that, but the receptionist said that was the only way to contact the doctor. I felt lost,” said Cavanaugh, a retired psychotherapist near Albany, New York.

Cavanaugh is far from alone. Many older people balk at the idea of communicating with their physicians over the internet. They may have limited digital skills, have physical challenges, or simply prefer human connection.

As medicine leans harder on electronic portals and telehealth, these patients are finding themselves shut out of their own care. Experts warn this approach deepens inequities in access to care and can worsen health outcomes.

Clinicians should “offer options for various types of communication, such as phone calls or texts, because whenever an older adult — or anyone, for that matter — is given a choice, they feel more empowered and more committed to their care,” said Susan Wehry, MD, associate clinical professor at the University of New England College of Osteopathic Medicine in Biddeford, Maine.
 

Tech Support

Use of medical communication tools varies among older adults. One study in JAMA Network Open found nearly two thirds of those older than 65 years who filled out surveys via phone or internet had used a patient portal, while a little under half used telehealth, and only 44% used a medical health application.

Older patients tend to fall into two camps, said Neela Patel, MD, MPH, CMD, chief of the Division of Geriatrics and Supportive Care at the UT Health San Antonio.

Her patients “are at two extremes of the spectrum — some technologically savvy and others with limited digital literacy or limited or no access to the Internet,” Patel, who is also the vice chair of the Health Systems Innovations and Technology Committee of the American Geriatric Society, said.

Patel’s practice has dedicated staff to help patients master certain technologies. For example, a pharmacist teaches patients how to use a glucometer and a blood pressure cuff. Other staff teach them how to use smartphone apps that track blood pressure or glucose.

She usually sees patients in person before offering telehealth as an option, ensuring the person has “enough digital literacy to utilize them and that the patient can see and hear the visit.”

If technological limitations impede a telehealth appointment, clinicians can help patients navigate their computer screen. Patel recounted the story of an older woman who was unable to come to the clinic in person, so had a telehealth visit instead.

“She had trouble hearing me, so I asked her to share her screen with me. I walked her through how to do that. Then I showed her where the ‘volume’ button was located. It turns out her volume was at zero,” Patel said. “Once that was adjusted, we were able to proceed with the appointment.”

Educating older adults on how to use health technology does not have to fall upon clinicians and their staff, according to Wehry. She routinely refers her patients to community resources to help them develop digital skills.

Local libraries and community centers often offer digital education. Some retirement communities and assisted living facilities also have tech support personnel or classes available to residents.

Wehry refers some of her patients to the National Digital Equity Center which teaches older adults how to hold a telehealth visit.

Roughly 90% of Patel’s patients are signed up for the patient portal, but they may not be operating the technology, she said. She advises these patients to ask their children or caregivers for help as appropriate. 

Teaching patients to use the communication technology early on can also be helpful in other ways. If patients who have been technologically proficient start having difficulty, “it’s a clue there may be cognitive changes, and we follow up on those,” Patel said.

Additional resources to help older adults develop digital competence include Cyber Seniors, Older Adults Technology Services, AARP, AARP Find Digital Courses, Area Agencies on Aging, and Senior Navigator.
 

Human Touch

Some older adults may simply want a more traditional means of communicating with their clinician. A review of 29 papers, encompassing over 6200 adults older than 60 years, identified several domains affecting the adoption of healthcare technology, two of which were resistance to new technology and having family or friends that could help with.

Wehry said many older adults “don’t resist this technology because they’re unable to figure out how to use it. Instead, they see the technology as too impersonal.”

One study found many older adults fear technologies may end up replacing face-to-face contact.

“I’m beginning to encourage primary care providers to take a step back and refocus on the doctor-patient relationship. When communication is limited to the technological approach, it can erode trust in that relationship,” Wehry said.

The American Medical Association recommends clinicians “provide a method other than electronic communication for patients who are without technological proficiency or access.”

Some busy clinicians might be concerned phone calls will be too time-consuming, Wehry said. Patients should be informed of hours of phone availability, how much time is allotted to calls, and how many days or hours a response may take. Clinicians might also use tools that allow patients to use their cell phone to text their practice with medical questions.

Cavanaugh ended up finding technological help from a professional organizer whom she hired to help rearrange her closets.

“She’s knowledgeable and patient, and she’s helping me with the portal,” she said. “If I hadn’t serendipitously found the organizer, I’d still be struggling and unable to access proper medical care.”

Wehry and Patel disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Beth Cavanaugh, 79, was starting a new medication when she ran into a modern hurdle: Her doctor’s office required all follow–up questions, even those about side effects of the drug, to go through the patient portal.

Cavanaugh said she did not know how to set up or use the system.

“I tried to explain that, but the receptionist said that was the only way to contact the doctor. I felt lost,” said Cavanaugh, a retired psychotherapist near Albany, New York.

Cavanaugh is far from alone. Many older people balk at the idea of communicating with their physicians over the internet. They may have limited digital skills, have physical challenges, or simply prefer human connection.

As medicine leans harder on electronic portals and telehealth, these patients are finding themselves shut out of their own care. Experts warn this approach deepens inequities in access to care and can worsen health outcomes.

Clinicians should “offer options for various types of communication, such as phone calls or texts, because whenever an older adult — or anyone, for that matter — is given a choice, they feel more empowered and more committed to their care,” said Susan Wehry, MD, associate clinical professor at the University of New England College of Osteopathic Medicine in Biddeford, Maine.
 

Tech Support

Use of medical communication tools varies among older adults. One study in JAMA Network Open found nearly two thirds of those older than 65 years who filled out surveys via phone or internet had used a patient portal, while a little under half used telehealth, and only 44% used a medical health application.

Older patients tend to fall into two camps, said Neela Patel, MD, MPH, CMD, chief of the Division of Geriatrics and Supportive Care at the UT Health San Antonio.

Her patients “are at two extremes of the spectrum — some technologically savvy and others with limited digital literacy or limited or no access to the Internet,” Patel, who is also the vice chair of the Health Systems Innovations and Technology Committee of the American Geriatric Society, said.

Patel’s practice has dedicated staff to help patients master certain technologies. For example, a pharmacist teaches patients how to use a glucometer and a blood pressure cuff. Other staff teach them how to use smartphone apps that track blood pressure or glucose.

She usually sees patients in person before offering telehealth as an option, ensuring the person has “enough digital literacy to utilize them and that the patient can see and hear the visit.”

If technological limitations impede a telehealth appointment, clinicians can help patients navigate their computer screen. Patel recounted the story of an older woman who was unable to come to the clinic in person, so had a telehealth visit instead.

“She had trouble hearing me, so I asked her to share her screen with me. I walked her through how to do that. Then I showed her where the ‘volume’ button was located. It turns out her volume was at zero,” Patel said. “Once that was adjusted, we were able to proceed with the appointment.”

Educating older adults on how to use health technology does not have to fall upon clinicians and their staff, according to Wehry. She routinely refers her patients to community resources to help them develop digital skills.

Local libraries and community centers often offer digital education. Some retirement communities and assisted living facilities also have tech support personnel or classes available to residents.

Wehry refers some of her patients to the National Digital Equity Center which teaches older adults how to hold a telehealth visit.

Roughly 90% of Patel’s patients are signed up for the patient portal, but they may not be operating the technology, she said. She advises these patients to ask their children or caregivers for help as appropriate. 

Teaching patients to use the communication technology early on can also be helpful in other ways. If patients who have been technologically proficient start having difficulty, “it’s a clue there may be cognitive changes, and we follow up on those,” Patel said.

Additional resources to help older adults develop digital competence include Cyber Seniors, Older Adults Technology Services, AARP, AARP Find Digital Courses, Area Agencies on Aging, and Senior Navigator.
 

Human Touch

Some older adults may simply want a more traditional means of communicating with their clinician. A review of 29 papers, encompassing over 6200 adults older than 60 years, identified several domains affecting the adoption of healthcare technology, two of which were resistance to new technology and having family or friends that could help with.

Wehry said many older adults “don’t resist this technology because they’re unable to figure out how to use it. Instead, they see the technology as too impersonal.”

One study found many older adults fear technologies may end up replacing face-to-face contact.

“I’m beginning to encourage primary care providers to take a step back and refocus on the doctor-patient relationship. When communication is limited to the technological approach, it can erode trust in that relationship,” Wehry said.

The American Medical Association recommends clinicians “provide a method other than electronic communication for patients who are without technological proficiency or access.”

Some busy clinicians might be concerned phone calls will be too time-consuming, Wehry said. Patients should be informed of hours of phone availability, how much time is allotted to calls, and how many days or hours a response may take. Clinicians might also use tools that allow patients to use their cell phone to text their practice with medical questions.

Cavanaugh ended up finding technological help from a professional organizer whom she hired to help rearrange her closets.

“She’s knowledgeable and patient, and she’s helping me with the portal,” she said. “If I hadn’t serendipitously found the organizer, I’d still be struggling and unable to access proper medical care.”

Wehry and Patel disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Fresenius Kabi USA has initiated a voluntary nationwide recall of three lots of famotidine injection, USP 20 mg/2 mL (10 mg/mL, 2 mL vial), according to a company announcement posted on the FDA website. 

The recall affects the following lot numbers 6133156 and 6133194, with expiration dates of August 2026, and lot number 6133388, with an expiration date of October 2026.

The recall stems from “out-of-specification endotoxin results in certain reserve samples of one lot,” the company said. The two additional lots are being recalled as a precaution. 

Elevated endotoxin levels may lead to severe systemic reactions, including sepsis, septic shock, inflammatory and life-threatening immune responses, and potentially death. 

Nonserious adverse events have been reported in association with lot 6133156, including chills, altered mental status, changes in respiratory status, fever/increased body temperature, shivering, and shaking. 

Famotidine injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers or as an alternative to the oral dosage forms for short-term use in patients unable to take oral medication for certain conditions, including active duodenal ulcer, benign gastric ulcer or gastroesophageal reflux disease, or maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer.

Clinicians should be alert for symptoms potentially related to endotoxin exposure in patients who have received the affected product; document use of the product in affected lots (if already administered) and monitor patients carefully; and inform prescribing clinicians and nursing staff so they can monitor for signs of endotoxin-related reaction.

Patients should be advised to contact their physician or healthcare provider if they experienced any problems that may be related to receiving the affected drug. 

Clinicians should check their inventory for famotidine injection USP 20 mg/2 mL vials; discontinue use, dispensing, and distribution of affected lots; and segregate and quarantine any affected units to prevent inadvertent use. 

For questions or product return coordination, contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459 or email at [email protected].

Adverse events or quality issues related to this recall should be reported to Fresenius Kabi (1-800-551-7176) and to the FDA MedWatch program. 
 

A version of this article appeared on Medscape.com.

Fresenius Kabi USA has initiated a voluntary nationwide recall of three lots of famotidine injection, USP 20 mg/2 mL (10 mg/mL, 2 mL vial), according to a company announcement posted on the FDA website. 

The recall affects the following lot numbers 6133156 and 6133194, with expiration dates of August 2026, and lot number 6133388, with an expiration date of October 2026.

The recall stems from “out-of-specification endotoxin results in certain reserve samples of one lot,” the company said. The two additional lots are being recalled as a precaution. 

Elevated endotoxin levels may lead to severe systemic reactions, including sepsis, septic shock, inflammatory and life-threatening immune responses, and potentially death. 

Nonserious adverse events have been reported in association with lot 6133156, including chills, altered mental status, changes in respiratory status, fever/increased body temperature, shivering, and shaking. 

Famotidine injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers or as an alternative to the oral dosage forms for short-term use in patients unable to take oral medication for certain conditions, including active duodenal ulcer, benign gastric ulcer or gastroesophageal reflux disease, or maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer.

Clinicians should be alert for symptoms potentially related to endotoxin exposure in patients who have received the affected product; document use of the product in affected lots (if already administered) and monitor patients carefully; and inform prescribing clinicians and nursing staff so they can monitor for signs of endotoxin-related reaction.

Patients should be advised to contact their physician or healthcare provider if they experienced any problems that may be related to receiving the affected drug. 

Clinicians should check their inventory for famotidine injection USP 20 mg/2 mL vials; discontinue use, dispensing, and distribution of affected lots; and segregate and quarantine any affected units to prevent inadvertent use. 

For questions or product return coordination, contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459 or email at [email protected].

Adverse events or quality issues related to this recall should be reported to Fresenius Kabi (1-800-551-7176) and to the FDA MedWatch program. 
 

A version of this article appeared on Medscape.com.

Fresenius Kabi USA has initiated a voluntary nationwide recall of three lots of famotidine injection, USP 20 mg/2 mL (10 mg/mL, 2 mL vial), according to a company announcement posted on the FDA website. 

The recall affects the following lot numbers 6133156 and 6133194, with expiration dates of August 2026, and lot number 6133388, with an expiration date of October 2026.

The recall stems from “out-of-specification endotoxin results in certain reserve samples of one lot,” the company said. The two additional lots are being recalled as a precaution. 

Elevated endotoxin levels may lead to severe systemic reactions, including sepsis, septic shock, inflammatory and life-threatening immune responses, and potentially death. 

Nonserious adverse events have been reported in association with lot 6133156, including chills, altered mental status, changes in respiratory status, fever/increased body temperature, shivering, and shaking. 

Famotidine injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers or as an alternative to the oral dosage forms for short-term use in patients unable to take oral medication for certain conditions, including active duodenal ulcer, benign gastric ulcer or gastroesophageal reflux disease, or maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer.

Clinicians should be alert for symptoms potentially related to endotoxin exposure in patients who have received the affected product; document use of the product in affected lots (if already administered) and monitor patients carefully; and inform prescribing clinicians and nursing staff so they can monitor for signs of endotoxin-related reaction.

Patients should be advised to contact their physician or healthcare provider if they experienced any problems that may be related to receiving the affected drug. 

Clinicians should check their inventory for famotidine injection USP 20 mg/2 mL vials; discontinue use, dispensing, and distribution of affected lots; and segregate and quarantine any affected units to prevent inadvertent use. 

For questions or product return coordination, contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459 or email at [email protected].

Adverse events or quality issues related to this recall should be reported to Fresenius Kabi (1-800-551-7176) and to the FDA MedWatch program. 
 

A version of this article appeared on Medscape.com.