The AGA Research Foundation, the charitable arm of the American Gastroenterological Association (AGA), plays an important role in medical research by providing grants to young scientists at a critical time in their career. The AGA Research Foundation’s mission is to raise funds to support young researchers in gastroenterology and hepatology.

The research program of the AGA has had an important impact on digestive disease research for the last 30 years. Ninety percent of investigators who received an AGA Research Scholar Award over the past 10 years have stayed in gastroenterology and hepatology research.

AGA grants have led to discoveries, including new approaches to down-regulate intestinal inflammation, a test for genetic predisposition to colon cancer, and autoimmune liver disease treatments. The importance of these awards is evidenced by the fact that virtually every major advance leading to the understanding, prevention, treatment, and cure of digestive diseases has been made in the research laboratory of a talented young investigator.

At a time when funds from the National Institutes of Health and other traditional sources of support are in decline, the AGA Research Foundation is committed and ready to support young investigators and fund discoveries that will continue to improve GI practice and better patient care.

The AGA Research Foundation provides a key source of funding at a critical juncture in a young researcher’s career. By joining AGA members and donors in donating to the AGA Research Foundation, you will ensure that researchers have opportunities to continue their life-saving work.

The AGA Research Foundation, the charitable arm of the American Gastroenterological Association (AGA), plays an important role in medical research by providing grants to young scientists at a critical time in their career. The AGA Research Foundation’s mission is to raise funds to support young researchers in gastroenterology and hepatology.

The research program of the AGA has had an important impact on digestive disease research for the last 30 years. Ninety percent of investigators who received an AGA Research Scholar Award over the past 10 years have stayed in gastroenterology and hepatology research.

AGA grants have led to discoveries, including new approaches to down-regulate intestinal inflammation, a test for genetic predisposition to colon cancer, and autoimmune liver disease treatments. The importance of these awards is evidenced by the fact that virtually every major advance leading to the understanding, prevention, treatment, and cure of digestive diseases has been made in the research laboratory of a talented young investigator.

At a time when funds from the National Institutes of Health and other traditional sources of support are in decline, the AGA Research Foundation is committed and ready to support young investigators and fund discoveries that will continue to improve GI practice and better patient care.

The AGA Research Foundation provides a key source of funding at a critical juncture in a young researcher’s career. By joining AGA members and donors in donating to the AGA Research Foundation, you will ensure that researchers have opportunities to continue their life-saving work.

The AGA Research Foundation, the charitable arm of the American Gastroenterological Association (AGA), plays an important role in medical research by providing grants to young scientists at a critical time in their career. The AGA Research Foundation’s mission is to raise funds to support young researchers in gastroenterology and hepatology.

The research program of the AGA has had an important impact on digestive disease research for the last 30 years. Ninety percent of investigators who received an AGA Research Scholar Award over the past 10 years have stayed in gastroenterology and hepatology research.

AGA grants have led to discoveries, including new approaches to down-regulate intestinal inflammation, a test for genetic predisposition to colon cancer, and autoimmune liver disease treatments. The importance of these awards is evidenced by the fact that virtually every major advance leading to the understanding, prevention, treatment, and cure of digestive diseases has been made in the research laboratory of a talented young investigator.

At a time when funds from the National Institutes of Health and other traditional sources of support are in decline, the AGA Research Foundation is committed and ready to support young investigators and fund discoveries that will continue to improve GI practice and better patient care.

The AGA Research Foundation provides a key source of funding at a critical juncture in a young researcher’s career. By joining AGA members and donors in donating to the AGA Research Foundation, you will ensure that researchers have opportunities to continue their life-saving work.

We are looking forward to seeing you in our hometown for Digestive Disease Week® (DDW) 2024!

As you plan your schedule, here’s a listing of AGA’s free networking events. For more details and featured programming, visit www.gastro.org/DDW.

American Gastroenterological Association

Meetups at AGA Central (L Street Bridge)

Network with like-minded attendees, build your #AGAGastroSquad and enjoy refreshments at our meetups.

Saturday, May 18

• 3 p.m.: Advocacy champions meetup – A “thank you” for everyone who supported our grassroots advocacy efforts this year!

Sunday, May 19

• 11 a.m.: NPPA meetup
• 1 p.m.: Dietitian meetup
• 3 p.m.: IBD meetup – Happy World IBD Day!

Monday, May 20

• 11 a.m.: Trainee meetup – Mingle with AGA journal editors!
• 1 p.m.: Psychologists meetup
• 3 p.m.: Clinician meetup

Tuesday, May 21

• 11 a.m.: Innovator meetup

RSVP and add to your calendar: www.signupgenius.com/go/10C0E4EA4AE2DA2F5C43-48529281-agacentral#/

Additional events for trainees

We have more opportunities for you to network at DDW! The following events all take place on Sunday, May 19.

• 10 a.m.: Live recording: Small Talk, Big Topics – Mingle with fellow trainees and early career GIs during a live recording of AGA’s podcast. Our hosts will interview fellowship program director Dr. Janice Jou.

[Location: AGA Central (L Street Bridge)]

• 1 p.m.: Meet-the-Experts: AGA Leadership – Held in the DDW Trainee and Early Career Lounge, these sessions are an opportunity for early career attendees to get tips from those further along in their career.

[Location: DDW Trainee and Early Career Lounge]

• 2 p.m.: AGA/DHPA Networking Hour – Join us for an hour of guided networking and 4-way Jeopardy!

[Location: DDW Trainee and Early Career Lounge]

We are looking forward to seeing you in our hometown for Digestive Disease Week® (DDW) 2024!

As you plan your schedule, here’s a listing of AGA’s free networking events. For more details and featured programming, visit www.gastro.org/DDW.

American Gastroenterological Association

Meetups at AGA Central (L Street Bridge)

Network with like-minded attendees, build your #AGAGastroSquad and enjoy refreshments at our meetups.

Saturday, May 18

• 3 p.m.: Advocacy champions meetup – A “thank you” for everyone who supported our grassroots advocacy efforts this year!

Sunday, May 19

• 11 a.m.: NPPA meetup
• 1 p.m.: Dietitian meetup
• 3 p.m.: IBD meetup – Happy World IBD Day!

Monday, May 20

• 11 a.m.: Trainee meetup – Mingle with AGA journal editors!
• 1 p.m.: Psychologists meetup
• 3 p.m.: Clinician meetup

Tuesday, May 21

• 11 a.m.: Innovator meetup

RSVP and add to your calendar: www.signupgenius.com/go/10C0E4EA4AE2DA2F5C43-48529281-agacentral#/

Additional events for trainees

We have more opportunities for you to network at DDW! The following events all take place on Sunday, May 19.

• 10 a.m.: Live recording: Small Talk, Big Topics – Mingle with fellow trainees and early career GIs during a live recording of AGA’s podcast. Our hosts will interview fellowship program director Dr. Janice Jou.

[Location: AGA Central (L Street Bridge)]

• 1 p.m.: Meet-the-Experts: AGA Leadership – Held in the DDW Trainee and Early Career Lounge, these sessions are an opportunity for early career attendees to get tips from those further along in their career.

[Location: DDW Trainee and Early Career Lounge]

• 2 p.m.: AGA/DHPA Networking Hour – Join us for an hour of guided networking and 4-way Jeopardy!

[Location: DDW Trainee and Early Career Lounge]

We are looking forward to seeing you in our hometown for Digestive Disease Week® (DDW) 2024!

As you plan your schedule, here’s a listing of AGA’s free networking events. For more details and featured programming, visit www.gastro.org/DDW.

American Gastroenterological Association

Meetups at AGA Central (L Street Bridge)

Network with like-minded attendees, build your #AGAGastroSquad and enjoy refreshments at our meetups.

Saturday, May 18

• 3 p.m.: Advocacy champions meetup – A “thank you” for everyone who supported our grassroots advocacy efforts this year!

Sunday, May 19

• 11 a.m.: NPPA meetup
• 1 p.m.: Dietitian meetup
• 3 p.m.: IBD meetup – Happy World IBD Day!

Monday, May 20

• 11 a.m.: Trainee meetup – Mingle with AGA journal editors!
• 1 p.m.: Psychologists meetup
• 3 p.m.: Clinician meetup

Tuesday, May 21

• 11 a.m.: Innovator meetup

RSVP and add to your calendar: www.signupgenius.com/go/10C0E4EA4AE2DA2F5C43-48529281-agacentral#/

Additional events for trainees

We have more opportunities for you to network at DDW! The following events all take place on Sunday, May 19.

• 10 a.m.: Live recording: Small Talk, Big Topics – Mingle with fellow trainees and early career GIs during a live recording of AGA’s podcast. Our hosts will interview fellowship program director Dr. Janice Jou.

[Location: AGA Central (L Street Bridge)]

• 1 p.m.: Meet-the-Experts: AGA Leadership – Held in the DDW Trainee and Early Career Lounge, these sessions are an opportunity for early career attendees to get tips from those further along in their career.

[Location: DDW Trainee and Early Career Lounge]

• 2 p.m.: AGA/DHPA Networking Hour – Join us for an hour of guided networking and 4-way Jeopardy!

[Location: DDW Trainee and Early Career Lounge]

Rep. Yadira Caraveo, MD (D-CO), recently introduced the Colorectal Cancer Early Detection Act along with Reps. Donald Payne Jr. (D-NJ), Haley Stevens (D-MI), and Terri Sewell (D-AL).

The Colorectal Cancer Early Detection Act would award grants to states to promote colorectal cancer prevention and early detection efforts to individuals under age 45.

• Screen increased risk and high-risk individuals under age 45 for colorectal cancer.
• Provide appropriate referrals for medical treatment.
• Develop and carry out a public education and awareness campaign for the detection and control of CRC.
• Improve the education and training of health providers in detecting and controlling CRC.
• Establish mechanisms through which states can monitor the quality of CRC screening procedures.
• Develop strategies to assess family history and genetic predispositions to CRC.
• Design patient and clinician decision support tools for CRC.
• Conduct surveillance to determine other risk factors for CRC in this population.

“Colorectal cancer is the second-leading cause of cancer death in the US and is increasing at an alarming rate in younger people. AGA celebrates Rep. Caraveo’s work to address this trend through education and awareness” said Barbara Jung, MD, AGA President.

We look forward to working with our congressional champions to increase screening rates and reverse the trend of early onset colorectal cancer!

Rep. Yadira Caraveo, MD (D-CO), recently introduced the Colorectal Cancer Early Detection Act along with Reps. Donald Payne Jr. (D-NJ), Haley Stevens (D-MI), and Terri Sewell (D-AL).

The Colorectal Cancer Early Detection Act would award grants to states to promote colorectal cancer prevention and early detection efforts to individuals under age 45.

• Screen increased risk and high-risk individuals under age 45 for colorectal cancer.
• Provide appropriate referrals for medical treatment.
• Develop and carry out a public education and awareness campaign for the detection and control of CRC.
• Improve the education and training of health providers in detecting and controlling CRC.
• Establish mechanisms through which states can monitor the quality of CRC screening procedures.
• Develop strategies to assess family history and genetic predispositions to CRC.
• Design patient and clinician decision support tools for CRC.
• Conduct surveillance to determine other risk factors for CRC in this population.

“Colorectal cancer is the second-leading cause of cancer death in the US and is increasing at an alarming rate in younger people. AGA celebrates Rep. Caraveo’s work to address this trend through education and awareness” said Barbara Jung, MD, AGA President.

We look forward to working with our congressional champions to increase screening rates and reverse the trend of early onset colorectal cancer!

Rep. Yadira Caraveo, MD (D-CO), recently introduced the Colorectal Cancer Early Detection Act along with Reps. Donald Payne Jr. (D-NJ), Haley Stevens (D-MI), and Terri Sewell (D-AL).

The Colorectal Cancer Early Detection Act would award grants to states to promote colorectal cancer prevention and early detection efforts to individuals under age 45.

• Screen increased risk and high-risk individuals under age 45 for colorectal cancer.
• Provide appropriate referrals for medical treatment.
• Develop and carry out a public education and awareness campaign for the detection and control of CRC.
• Improve the education and training of health providers in detecting and controlling CRC.
• Establish mechanisms through which states can monitor the quality of CRC screening procedures.
• Develop strategies to assess family history and genetic predispositions to CRC.
• Design patient and clinician decision support tools for CRC.
• Conduct surveillance to determine other risk factors for CRC in this population.

“Colorectal cancer is the second-leading cause of cancer death in the US and is increasing at an alarming rate in younger people. AGA celebrates Rep. Caraveo’s work to address this trend through education and awareness” said Barbara Jung, MD, AGA President.

We look forward to working with our congressional champions to increase screening rates and reverse the trend of early onset colorectal cancer!

Read More

Read More

Read More

American Gastroenterological Association (AGA) has published a clinical practice update detailing best practices for performing a high-quality upper endoscopy exam.

The update, authored by Satish Nagula, MD, of Icahn School of Medicine at Mount Sinai, New York, NY, and colleagues, includes nine pieces of best practice advice that address procedure optimization, evaluation of suspected premalignancy, and postprocedure follow-up evaluation.

Courtesy Mount Sinai

“Defining what constitutes a high-quality esophagogastroduodenoscopy (EGD) poses somewhat of a challenge because the spectrum of indications and the breadth of benign and (pre)malignant disease pathology in the upper GI tract is very broad,” the update panelists wrote in Clinical Gastroenterology and Hepatology. “Standardizing the measures defining a high-quality upper endoscopic examination is one of the first steps for assessing quality.”
 

Preprocedure Recommendations

Dr. Nagula and colleagues first emphasized that EGD should be performed for an appropriate indication, citing a recent meta-analysis that found 21.7% of upper endoscopy procedures were performed for an inappropriate indication. Of note, diagnostic yields were 42% higher in procedures performed for an appropriate indication.

After ensuring an appropriate indication, the update also encourages clinicians to inform patients of the various benefits, risks, and alternatives of the procedure prior to providing consent.
 

Intraprocedure Recommendations

During the procedure, endoscopists should take several steps to ensure optimal visualization of tissues, according to the update.

First, a high-definition (HD) white-light endoscopy system should be employed.

“Although HD imaging is a standard feature of newer-generation endoscopes, legacy standard-definition scopes remain in use,” Dr. Nagula and colleagues noted. “Moreover, to provide true HD image resolution, each component of the system (eg, the endoscope video chip, the processor, the monitor, and transmission cables) must be HD compatible.”

This HD-compatible system should be coupled with image-enhancing technology to further improve lesion detection. In Barrett’s esophagus, the panelists noted, image enhancement can improve lesion detection as much as 20%.

They predicted that AI-assisted software may boost detection rates even higher: “Computer-aided detection and computer-aided diagnosis systems for upper endoscopy are still in the early phases of development but do show similar promise for improving the detection and characterization of upper GI tract neoplasia.”

Beyond selection of best available technologies, the update encourages more fundamental strategies to improve visualization, including mucosal cleansing and insufflation, with sufficient time spent inspecting the foregut mucosa via anterograde and retroflexed views.

Where appropriate, standardized biopsy protocols should be followed to evaluate and manage foregut conditions.
 

Postprocedure Recommendations

After the procedure, endoscopists should offer patients management recommendations based on the endoscopic findings and, if necessary, notify them that more recommendations may be forthcoming based on histopathology results, according to the update.

Similarly, endoscopists should follow established surveillance intervals for future procedures, with modifications made as needed, based on histopathology findings.
 

Document, Document, Document

Throughout the update, Dr. Nagula and colleagues repeatedly emphasize the importance of documentation, from preprocedural discussions with patients through planned surveillance schedules.

However, the recommendations are clear about “weighing the practical implications” of “onerous” documentation, particularly photodocumentation requirements. For instance, the authors note that “there are some scenarios in which more rigorous photodocumentation standards during upper endoscopy should be considered, such as patients with risk factors for neoplasia,” but at the very least “photodocumentation of any suspicious abnormalities, ideally with annotations, is strongly advised.”
 

Moving Toward Quality Standardization for Upper Endoscopy

“These best practice advice statements are intended to improve measurable clinical, patient-reported, and economic healthcare outcomes and are not meant to put an additional burden on endoscopists,” the panelists wrote. “Ideally, future research will set threshold indicators of adherence to these best practices that optimally are associated with these aforementioned objective outcomes.”

This update was commissioned and approved by AGA. The update panelists disclosed relationships with Covidien LP, Fujifilm USA, Mahana Therapeutics, and others.

American Gastroenterological Association (AGA) has published a clinical practice update detailing best practices for performing a high-quality upper endoscopy exam.

The update, authored by Satish Nagula, MD, of Icahn School of Medicine at Mount Sinai, New York, NY, and colleagues, includes nine pieces of best practice advice that address procedure optimization, evaluation of suspected premalignancy, and postprocedure follow-up evaluation.

Courtesy Mount Sinai

“Defining what constitutes a high-quality esophagogastroduodenoscopy (EGD) poses somewhat of a challenge because the spectrum of indications and the breadth of benign and (pre)malignant disease pathology in the upper GI tract is very broad,” the update panelists wrote in Clinical Gastroenterology and Hepatology. “Standardizing the measures defining a high-quality upper endoscopic examination is one of the first steps for assessing quality.”
 

Preprocedure Recommendations

Dr. Nagula and colleagues first emphasized that EGD should be performed for an appropriate indication, citing a recent meta-analysis that found 21.7% of upper endoscopy procedures were performed for an inappropriate indication. Of note, diagnostic yields were 42% higher in procedures performed for an appropriate indication.

After ensuring an appropriate indication, the update also encourages clinicians to inform patients of the various benefits, risks, and alternatives of the procedure prior to providing consent.
 

Intraprocedure Recommendations

During the procedure, endoscopists should take several steps to ensure optimal visualization of tissues, according to the update.

First, a high-definition (HD) white-light endoscopy system should be employed.

“Although HD imaging is a standard feature of newer-generation endoscopes, legacy standard-definition scopes remain in use,” Dr. Nagula and colleagues noted. “Moreover, to provide true HD image resolution, each component of the system (eg, the endoscope video chip, the processor, the monitor, and transmission cables) must be HD compatible.”

This HD-compatible system should be coupled with image-enhancing technology to further improve lesion detection. In Barrett’s esophagus, the panelists noted, image enhancement can improve lesion detection as much as 20%.

They predicted that AI-assisted software may boost detection rates even higher: “Computer-aided detection and computer-aided diagnosis systems for upper endoscopy are still in the early phases of development but do show similar promise for improving the detection and characterization of upper GI tract neoplasia.”

Beyond selection of best available technologies, the update encourages more fundamental strategies to improve visualization, including mucosal cleansing and insufflation, with sufficient time spent inspecting the foregut mucosa via anterograde and retroflexed views.

Where appropriate, standardized biopsy protocols should be followed to evaluate and manage foregut conditions.
 

Postprocedure Recommendations

After the procedure, endoscopists should offer patients management recommendations based on the endoscopic findings and, if necessary, notify them that more recommendations may be forthcoming based on histopathology results, according to the update.

Similarly, endoscopists should follow established surveillance intervals for future procedures, with modifications made as needed, based on histopathology findings.
 

Document, Document, Document

Throughout the update, Dr. Nagula and colleagues repeatedly emphasize the importance of documentation, from preprocedural discussions with patients through planned surveillance schedules.

However, the recommendations are clear about “weighing the practical implications” of “onerous” documentation, particularly photodocumentation requirements. For instance, the authors note that “there are some scenarios in which more rigorous photodocumentation standards during upper endoscopy should be considered, such as patients with risk factors for neoplasia,” but at the very least “photodocumentation of any suspicious abnormalities, ideally with annotations, is strongly advised.”
 

Moving Toward Quality Standardization for Upper Endoscopy

“These best practice advice statements are intended to improve measurable clinical, patient-reported, and economic healthcare outcomes and are not meant to put an additional burden on endoscopists,” the panelists wrote. “Ideally, future research will set threshold indicators of adherence to these best practices that optimally are associated with these aforementioned objective outcomes.”

This update was commissioned and approved by AGA. The update panelists disclosed relationships with Covidien LP, Fujifilm USA, Mahana Therapeutics, and others.

American Gastroenterological Association (AGA) has published a clinical practice update detailing best practices for performing a high-quality upper endoscopy exam.

The update, authored by Satish Nagula, MD, of Icahn School of Medicine at Mount Sinai, New York, NY, and colleagues, includes nine pieces of best practice advice that address procedure optimization, evaluation of suspected premalignancy, and postprocedure follow-up evaluation.

Courtesy Mount Sinai

“Defining what constitutes a high-quality esophagogastroduodenoscopy (EGD) poses somewhat of a challenge because the spectrum of indications and the breadth of benign and (pre)malignant disease pathology in the upper GI tract is very broad,” the update panelists wrote in Clinical Gastroenterology and Hepatology. “Standardizing the measures defining a high-quality upper endoscopic examination is one of the first steps for assessing quality.”
 

Preprocedure Recommendations

Dr. Nagula and colleagues first emphasized that EGD should be performed for an appropriate indication, citing a recent meta-analysis that found 21.7% of upper endoscopy procedures were performed for an inappropriate indication. Of note, diagnostic yields were 42% higher in procedures performed for an appropriate indication.

After ensuring an appropriate indication, the update also encourages clinicians to inform patients of the various benefits, risks, and alternatives of the procedure prior to providing consent.
 

Intraprocedure Recommendations

During the procedure, endoscopists should take several steps to ensure optimal visualization of tissues, according to the update.

First, a high-definition (HD) white-light endoscopy system should be employed.

“Although HD imaging is a standard feature of newer-generation endoscopes, legacy standard-definition scopes remain in use,” Dr. Nagula and colleagues noted. “Moreover, to provide true HD image resolution, each component of the system (eg, the endoscope video chip, the processor, the monitor, and transmission cables) must be HD compatible.”

This HD-compatible system should be coupled with image-enhancing technology to further improve lesion detection. In Barrett’s esophagus, the panelists noted, image enhancement can improve lesion detection as much as 20%.

They predicted that AI-assisted software may boost detection rates even higher: “Computer-aided detection and computer-aided diagnosis systems for upper endoscopy are still in the early phases of development but do show similar promise for improving the detection and characterization of upper GI tract neoplasia.”

Beyond selection of best available technologies, the update encourages more fundamental strategies to improve visualization, including mucosal cleansing and insufflation, with sufficient time spent inspecting the foregut mucosa via anterograde and retroflexed views.

Where appropriate, standardized biopsy protocols should be followed to evaluate and manage foregut conditions.
 

Postprocedure Recommendations

After the procedure, endoscopists should offer patients management recommendations based on the endoscopic findings and, if necessary, notify them that more recommendations may be forthcoming based on histopathology results, according to the update.

Similarly, endoscopists should follow established surveillance intervals for future procedures, with modifications made as needed, based on histopathology findings.
 

Document, Document, Document

Throughout the update, Dr. Nagula and colleagues repeatedly emphasize the importance of documentation, from preprocedural discussions with patients through planned surveillance schedules.

However, the recommendations are clear about “weighing the practical implications” of “onerous” documentation, particularly photodocumentation requirements. For instance, the authors note that “there are some scenarios in which more rigorous photodocumentation standards during upper endoscopy should be considered, such as patients with risk factors for neoplasia,” but at the very least “photodocumentation of any suspicious abnormalities, ideally with annotations, is strongly advised.”
 

Moving Toward Quality Standardization for Upper Endoscopy

“These best practice advice statements are intended to improve measurable clinical, patient-reported, and economic healthcare outcomes and are not meant to put an additional burden on endoscopists,” the panelists wrote. “Ideally, future research will set threshold indicators of adherence to these best practices that optimally are associated with these aforementioned objective outcomes.”

This update was commissioned and approved by AGA. The update panelists disclosed relationships with Covidien LP, Fujifilm USA, Mahana Therapeutics, and others.

Migraine attacks are classified as chronic or episodic. Chronic migraines occur at least 15 days a month, and often prove functionally debilitating. In 2018, therapies that target the calcitonin gene-related peptide (CGRP) were first introduced to help manage migraine attacks.

Dr Stephanie Nahas from Thomas Jefferson University in Philadelphia, Pennsylvania, discusses optimal approaches for incorporating these therapies, which include small molecule agents called gepants, and monoclonal antibodies. In both cases, these therapies prevent CGRP from binding to its receptor, which helps to reduce migraine symptomatology, both acutely and over time

According to Dr Nahas, the choice of therapy for an individual patient depends primarily on patient preferences. Most gepants are administered orally, and monoclonal antibodies are injected.

Dr Nahas  recommends that these therapies should be considered when a previous treatment proves insufficient to reduce disease burden to the degree that allows improved functioning and quality of life for the patient.

--

Stephanie J. Nahas-Geiger, MD, MSEd, Associate Professor, Department of Neurology, Division of Headache Medicine, Thomas Jefferson University; Assistant Director, Headache Medicine Fellowship Program, Jefferson Headache Center, Philadelphia, Pennsylvania

Stephanie J. Nahas-Geiger, MD, MSEd, has disclosed the following relevant financial relationships:
Serve(d) as a consultant for: AbbVie; Eli Lilly; Lundbeck; Pfizer; Theranica; Tonix (no relationships are active)

Migraine attacks are classified as chronic or episodic. Chronic migraines occur at least 15 days a month, and often prove functionally debilitating. In 2018, therapies that target the calcitonin gene-related peptide (CGRP) were first introduced to help manage migraine attacks.

Dr Stephanie Nahas from Thomas Jefferson University in Philadelphia, Pennsylvania, discusses optimal approaches for incorporating these therapies, which include small molecule agents called gepants, and monoclonal antibodies. In both cases, these therapies prevent CGRP from binding to its receptor, which helps to reduce migraine symptomatology, both acutely and over time

According to Dr Nahas, the choice of therapy for an individual patient depends primarily on patient preferences. Most gepants are administered orally, and monoclonal antibodies are injected.

Dr Nahas  recommends that these therapies should be considered when a previous treatment proves insufficient to reduce disease burden to the degree that allows improved functioning and quality of life for the patient.

--

Stephanie J. Nahas-Geiger, MD, MSEd, Associate Professor, Department of Neurology, Division of Headache Medicine, Thomas Jefferson University; Assistant Director, Headache Medicine Fellowship Program, Jefferson Headache Center, Philadelphia, Pennsylvania

Stephanie J. Nahas-Geiger, MD, MSEd, has disclosed the following relevant financial relationships:
Serve(d) as a consultant for: AbbVie; Eli Lilly; Lundbeck; Pfizer; Theranica; Tonix (no relationships are active)

Migraine attacks are classified as chronic or episodic. Chronic migraines occur at least 15 days a month, and often prove functionally debilitating. In 2018, therapies that target the calcitonin gene-related peptide (CGRP) were first introduced to help manage migraine attacks.

Dr Stephanie Nahas from Thomas Jefferson University in Philadelphia, Pennsylvania, discusses optimal approaches for incorporating these therapies, which include small molecule agents called gepants, and monoclonal antibodies. In both cases, these therapies prevent CGRP from binding to its receptor, which helps to reduce migraine symptomatology, both acutely and over time

According to Dr Nahas, the choice of therapy for an individual patient depends primarily on patient preferences. Most gepants are administered orally, and monoclonal antibodies are injected.

Dr Nahas  recommends that these therapies should be considered when a previous treatment proves insufficient to reduce disease burden to the degree that allows improved functioning and quality of life for the patient.

--

Stephanie J. Nahas-Geiger, MD, MSEd, Associate Professor, Department of Neurology, Division of Headache Medicine, Thomas Jefferson University; Assistant Director, Headache Medicine Fellowship Program, Jefferson Headache Center, Philadelphia, Pennsylvania

Stephanie J. Nahas-Geiger, MD, MSEd, has disclosed the following relevant financial relationships:
Serve(d) as a consultant for: AbbVie; Eli Lilly; Lundbeck; Pfizer; Theranica; Tonix (no relationships are active)

Episodic migraine occurs fewer than 15 days per month but can become chronic if poorly controlled. It is estimated that preventive therapy is indicated in over one third of patients with episodic migraine. Dr Barbara Nye from Wake Forest University in Winston-Salem, North Carolina, discusses optimal approaches for managing episodic migraine. According to Dr Nye, several factors, including patient preference, clinical evidence, and insurance coverage, will help inform which treatments can be offered.

She mentions that currently approved treatments include nonspecific therapeutics such as antiseizure, antidepressant, and blood pressure medications. Newer therapies known as gepants and injectable monoclonal antibodies are also available to manage and prevent episodic migraine.

Dr Nye concludes that the appropriate therapeutic goal is a reduction in headache frequency, reduction in headache severity, and improved response to medications, as well as decreasing the level of disability that patients are experiencing.

--

Barbara L. Nye, MD, Associate Professor of Neurology, Wake Forest University; Director, Headache Fellowship, Department of Neurology, Atrium Health Wake Forest Baptist, Winston-Salem, North Carolina

Barbara L. Nye, MD, has disclosed no relevant financial relationships.

Episodic migraine occurs fewer than 15 days per month but can become chronic if poorly controlled. It is estimated that preventive therapy is indicated in over one third of patients with episodic migraine. Dr Barbara Nye from Wake Forest University in Winston-Salem, North Carolina, discusses optimal approaches for managing episodic migraine. According to Dr Nye, several factors, including patient preference, clinical evidence, and insurance coverage, will help inform which treatments can be offered.

She mentions that currently approved treatments include nonspecific therapeutics such as antiseizure, antidepressant, and blood pressure medications. Newer therapies known as gepants and injectable monoclonal antibodies are also available to manage and prevent episodic migraine.

Dr Nye concludes that the appropriate therapeutic goal is a reduction in headache frequency, reduction in headache severity, and improved response to medications, as well as decreasing the level of disability that patients are experiencing.

--

Barbara L. Nye, MD, Associate Professor of Neurology, Wake Forest University; Director, Headache Fellowship, Department of Neurology, Atrium Health Wake Forest Baptist, Winston-Salem, North Carolina

Barbara L. Nye, MD, has disclosed no relevant financial relationships.

Episodic migraine occurs fewer than 15 days per month but can become chronic if poorly controlled. It is estimated that preventive therapy is indicated in over one third of patients with episodic migraine. Dr Barbara Nye from Wake Forest University in Winston-Salem, North Carolina, discusses optimal approaches for managing episodic migraine. According to Dr Nye, several factors, including patient preference, clinical evidence, and insurance coverage, will help inform which treatments can be offered.

She mentions that currently approved treatments include nonspecific therapeutics such as antiseizure, antidepressant, and blood pressure medications. Newer therapies known as gepants and injectable monoclonal antibodies are also available to manage and prevent episodic migraine.

Dr Nye concludes that the appropriate therapeutic goal is a reduction in headache frequency, reduction in headache severity, and improved response to medications, as well as decreasing the level of disability that patients are experiencing.

--

Barbara L. Nye, MD, Associate Professor of Neurology, Wake Forest University; Director, Headache Fellowship, Department of Neurology, Atrium Health Wake Forest Baptist, Winston-Salem, North Carolina

Barbara L. Nye, MD, has disclosed no relevant financial relationships.

Migraine can be divided into two broad categories: episodic, in which attacks occur between two and four times a month; and chronic, in which individuals suffer from headaches for at least half the month and experience at least eight attacks.

Acute treatment is fundamental to reducing the immediate disability of migraine attack in both types, and several effective migraine-specific therapies have been approved.

Dr Jessica Ailani, director of the Headache Center at Medstar Georgetown University Hospital, Washington, DC, discusses the benefits, potential side effects, and optimal use of migraine-specific therapies available for acute migraine, including how they can be used to build an effective treatment plan for an individual patient.

These include triptans (5-HT1B/1D receptor agonists), ergotamines (dihydroergotamine), neuromodulation devices, ditans (5-HT1F agonists), and gepants (CGRP antagonists).

--

Jessica Ailani, MD, Professor of Clinical Neurology, Director, Headache Center, Medstar Georgetown University Hospital, Washington, DC

Jessica Ailani, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; Aeon; electroCore; Dr. Reddy; Eli-Lilly; GlaxoSmithKline (2023); Lundbeck; Linpharma; Ipsen; Merz; Miravo; Pfizer; Neurolief; Gore; Satsuma; Scilex; Theranica; Tonix

Received research grant from: Parema; Ipsen; Lundbeck

Migraine can be divided into two broad categories: episodic, in which attacks occur between two and four times a month; and chronic, in which individuals suffer from headaches for at least half the month and experience at least eight attacks.

Acute treatment is fundamental to reducing the immediate disability of migraine attack in both types, and several effective migraine-specific therapies have been approved.

Dr Jessica Ailani, director of the Headache Center at Medstar Georgetown University Hospital, Washington, DC, discusses the benefits, potential side effects, and optimal use of migraine-specific therapies available for acute migraine, including how they can be used to build an effective treatment plan for an individual patient.

These include triptans (5-HT1B/1D receptor agonists), ergotamines (dihydroergotamine), neuromodulation devices, ditans (5-HT1F agonists), and gepants (CGRP antagonists).

--

Jessica Ailani, MD, Professor of Clinical Neurology, Director, Headache Center, Medstar Georgetown University Hospital, Washington, DC

Jessica Ailani, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; Aeon; electroCore; Dr. Reddy; Eli-Lilly; GlaxoSmithKline (2023); Lundbeck; Linpharma; Ipsen; Merz; Miravo; Pfizer; Neurolief; Gore; Satsuma; Scilex; Theranica; Tonix

Received research grant from: Parema; Ipsen; Lundbeck

Migraine can be divided into two broad categories: episodic, in which attacks occur between two and four times a month; and chronic, in which individuals suffer from headaches for at least half the month and experience at least eight attacks.

Acute treatment is fundamental to reducing the immediate disability of migraine attack in both types, and several effective migraine-specific therapies have been approved.

Dr Jessica Ailani, director of the Headache Center at Medstar Georgetown University Hospital, Washington, DC, discusses the benefits, potential side effects, and optimal use of migraine-specific therapies available for acute migraine, including how they can be used to build an effective treatment plan for an individual patient.

These include triptans (5-HT1B/1D receptor agonists), ergotamines (dihydroergotamine), neuromodulation devices, ditans (5-HT1F agonists), and gepants (CGRP antagonists).

--

Jessica Ailani, MD, Professor of Clinical Neurology, Director, Headache Center, Medstar Georgetown University Hospital, Washington, DC

Jessica Ailani, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; Aeon; electroCore; Dr. Reddy; Eli-Lilly; GlaxoSmithKline (2023); Lundbeck; Linpharma; Ipsen; Merz; Miravo; Pfizer; Neurolief; Gore; Satsuma; Scilex; Theranica; Tonix

Received research grant from: Parema; Ipsen; Lundbeck

Migraine can be divided into two broad categories: episodic, in which attacks occur between two and four times a month; and chronic, in which individuals suffer from headaches for at least half the month and experience at least eight attacks.

Acute treatment is fundamental to reducing the immediate disability of migraine attack in both types, and several effective migraine-specific therapies have been approved.

Dr Jessica Ailani, director of the Headache Center at Medstar Georgetown University Hospital, Washington, DC, discusses the benefits, potential side effects, and optimal use of migraine-specific therapies available for acute migraine, including how they can be used to build an effective treatment plan for an individual patient.

These include triptans (5-HT1B/1D receptor agonists), ergotamines (dihydroergotamine), neuromodulation devices, ditans (5-HT1F agonists), and gepants (CGRP antagonists).

--

Jessica Ailani, MD, Professor of Clinical Neurology, Director, Headache Center, Medstar Georgetown University Hospital, Washington, DC

Jessica Ailani, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; Aeon; electroCore; Dr. Reddy; Eli-Lilly; GlaxoSmithKline (2023); Lundbeck; Linpharma; Ipsen; Merz; Miravo; Pfizer; Neurolief; Gore; Satsuma; Scilex; Theranica; Tonix

Received research grant from: Parema; Ipsen; Lundbeck

Migraine can be divided into two broad categories: episodic, in which attacks occur between two and four times a month; and chronic, in which individuals suffer from headaches for at least half the month and experience at least eight attacks.

Acute treatment is fundamental to reducing the immediate disability of migraine attack in both types, and several effective migraine-specific therapies have been approved.

Dr Jessica Ailani, director of the Headache Center at Medstar Georgetown University Hospital, Washington, DC, discusses the benefits, potential side effects, and optimal use of migraine-specific therapies available for acute migraine, including how they can be used to build an effective treatment plan for an individual patient.

These include triptans (5-HT1B/1D receptor agonists), ergotamines (dihydroergotamine), neuromodulation devices, ditans (5-HT1F agonists), and gepants (CGRP antagonists).

--

Jessica Ailani, MD, Professor of Clinical Neurology, Director, Headache Center, Medstar Georgetown University Hospital, Washington, DC

Jessica Ailani, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; Aeon; electroCore; Dr. Reddy; Eli-Lilly; GlaxoSmithKline (2023); Lundbeck; Linpharma; Ipsen; Merz; Miravo; Pfizer; Neurolief; Gore; Satsuma; Scilex; Theranica; Tonix

Received research grant from: Parema; Ipsen; Lundbeck

Migraine can be divided into two broad categories: episodic, in which attacks occur between two and four times a month; and chronic, in which individuals suffer from headaches for at least half the month and experience at least eight attacks.

Acute treatment is fundamental to reducing the immediate disability of migraine attack in both types, and several effective migraine-specific therapies have been approved.

Dr Jessica Ailani, director of the Headache Center at Medstar Georgetown University Hospital, Washington, DC, discusses the benefits, potential side effects, and optimal use of migraine-specific therapies available for acute migraine, including how they can be used to build an effective treatment plan for an individual patient.

These include triptans (5-HT1B/1D receptor agonists), ergotamines (dihydroergotamine), neuromodulation devices, ditans (5-HT1F agonists), and gepants (CGRP antagonists).

--

Jessica Ailani, MD, Professor of Clinical Neurology, Director, Headache Center, Medstar Georgetown University Hospital, Washington, DC

Jessica Ailani, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; Aeon; electroCore; Dr. Reddy; Eli-Lilly; GlaxoSmithKline (2023); Lundbeck; Linpharma; Ipsen; Merz; Miravo; Pfizer; Neurolief; Gore; Satsuma; Scilex; Theranica; Tonix

Received research grant from: Parema; Ipsen; Lundbeck

SAN DIEGO — A novel multicancer early detection (MCED) blood test has demonstrated promising real-world results in detecting new cancers, including several cases of early-stage disease.

This was the conclusion of recent data presented by Ora Karp Gordon, MD, MS, during a session at the American Association for Cancer Research annual meeting.

The MCED test, known as Galleri, was made clinically available in the United States in April 2021. Developed by GRAIL LLC, the test analyzes cell-free DNA in the blood using targeted methylation analysis and machine learning to detect the presence of a cancer signal and determine its organ of origin or cancer signal origin. The initial screening of over 53,000 individuals with the Galleri test detected a cancer signal in 1.1% of participants.

The new real-world analysis examines the outcomes of repeat MCED testing in 5,794 individuals.

The study looked at individuals who initially received a ‘no cancer signal detected’ result and then underwent a second Galleri test. Over 80% of participants received their follow-up test 10-18 months after the first, with a median interval between blood draws of 12.9 months.

“The repeat tests detect those cancer cases that have reached the detection threshold since their last MCED test, which should be less than one year of incidence,” Dr. Gordon, professor at Saint John’s Cancer Institute, Santa Monica, California, said in an interview. “We are just now starting to see results from patients who get their second and even third round of screening.”

“Galleri is recommended to be used annually in addition to USPSTF [US Preventive Services Task Force]–recommended cancer screening tests, like mammography and colonoscopy,” she said.

This recommendation is based on a modeling study suggesting that annual screening would improve stage shift, diagnostic yield, and potentially mortality when compared to biennial screening, although biennial screening was still favorable compared with no screening, she explained.
 

Early Real-World Evidence of Repeat Testing

Among the cohort of 5,794 individuals who received repeat testing, 26 received a positive cancer signal on their second test, yielding a cancer signal detection rate of 0.45% (95% CI: 0.31%-0.66%). The cancer signal detection rate was slightly higher in men. The rate was 0.50% (95% CI: 0.32%-0.81%; 17 of 3367) in men versus 0.37% (95% CI: 0.2%-0.7%; 9 of 2427) in women.

During her presentation, Dr. Gordon highlighted that the repeat testing signal detection rate was lower than the initial 0.95% rate (95% CI: 0.87-1.0; 510 of 53,744) seen in the previous larger cohort of patients who were retested at 1 year.

She acknowledged that the lower cancer signal detection rate of repeat testing may indicate some degree of ‘early adopter’ bias, where those who return for a second test are systematically different from the general screening population. This could suggest that broader population-level screening may yield different results, she continued.
 

Shift Toward Unscreened Cancers

The top cancer types identified in the second round of testing were lymphoid, head and neck, bladder/urothelial, colorectal, and anal cancers. Clinicians were able to confirm clinical outcomes in 12 of 26 cases, in which cancer signals were detected. Of those 12 cases, 8 individuals received a cancer diagnosis and 4 did not have cancer. The remaining 14 of 26 cases in which cancer signals were detected are still under investigation.

“We found a shift away from USPSTF screen-detected cancers, like breast, lung, and prostate, and relative increase in unscreened urinary, head and neck, and lymphoid cancers, with 75% of cancers being those without any screening guidelines,” Dr. Gordon said in an interview.

She added that patients who choose to retest may have different cancer rates for several reasons, including bias toward a population that is health conscious and adhered to all recommended cancer screening.

“So the shift toward unscreened cancers is not unexpected and highlights the value of Galleri,” she said, but also acknowledged that “continued monitoring is needed to see if this translates in a persistent finding over time and tests.”
 

Shift Toward Early-Stage Cancers

Staging information was available for five cases, and Dr. Gordon highlighted in her talk that four of these confirmed cancers were stage I, including cancers of the anus, head and neck, bladder, and lymphoma. The fifth confirmed cancer with staging information was stage IV ovarian cancer.

“It is still early, and the numbers are very small, but the detection of early-stage cancers with second annual testing is very encouraging as these are the cases where MCED testing could have the greatest impact in improving outcomes through earlier treatment,” Dr. Gordon told this publication.

During an interview after the talk, Kenneth L. Kehl, MD, MPH, echoed that data must be confirmed in larger cohorts.

“The shift toward earlier stage cancers that are less detectable by standard screening methods is an interesting result, but we need to be cautious since the numbers were relatively small, and we do not have data on cancers that were diagnosed among patients whose second MCED test was also negative,” said Dr. Kehl, a medical oncologist at Dana-Farber Cancer Institute, Boston.
 

MCED Results Could Help Direct Diagnostic Workup

The test’s ability to predict the organ of origin was highly accurate, correctly identifying the cancer type in all eight confirmed cases. Among the eight cases with a confirmed cancer diagnosis, the accuracy of the first prediction was 100%, and diagnoses included invasive cancers across multiple tissues and organs, including anus, colon, head and neck, urothelial tract, ovary, and the lymphatic system.

“The fact that the site of origin for 100% of confirmed cancers was accurately predicted with GRAIL’s CSO by Galleri test confirms the promise that this can guide workup when a cancer signal is detected,” Dr. Gordon noted in the interview.
 

Looking Ahead

Dr. Kehl, who was not involved in the MCED study, noted in an interview that “further data on test characteristics beyond positive predictive value, including the sensitivity, specificity, and negative predictive value, as well as demonstration of clinical benefit — ideally in a randomized trial — will likely be required for MCED testing to become a standard public health recommendation.”

He added that challenges associated with implementing annual screening with MCED tests include the risks of both false positives and false negatives as testing becomes more widely available.

“False positives cause anxiety and lead to additional testing that may carry its own risks, and we need to understand if potentially false negative tests will be associated with less uptake of established screening strategies,” Dr. Kehl said in an interview. However, he noted that serial testing could lead to more frequent diagnoses of early-stage cancers that may be less detectable by standard methods.

Dr. Gordon reported financial relationships with GRAIL LLC and Genetic Technologies Corporation. Dr. Kehl reported no relationships with entities whose primary business is producing, marketing, selling, reselling, or distributing healthcare products used by or on patients.

SAN DIEGO — A novel multicancer early detection (MCED) blood test has demonstrated promising real-world results in detecting new cancers, including several cases of early-stage disease.

This was the conclusion of recent data presented by Ora Karp Gordon, MD, MS, during a session at the American Association for Cancer Research annual meeting.

The MCED test, known as Galleri, was made clinically available in the United States in April 2021. Developed by GRAIL LLC, the test analyzes cell-free DNA in the blood using targeted methylation analysis and machine learning to detect the presence of a cancer signal and determine its organ of origin or cancer signal origin. The initial screening of over 53,000 individuals with the Galleri test detected a cancer signal in 1.1% of participants.

The new real-world analysis examines the outcomes of repeat MCED testing in 5,794 individuals.

The study looked at individuals who initially received a ‘no cancer signal detected’ result and then underwent a second Galleri test. Over 80% of participants received their follow-up test 10-18 months after the first, with a median interval between blood draws of 12.9 months.

“The repeat tests detect those cancer cases that have reached the detection threshold since their last MCED test, which should be less than one year of incidence,” Dr. Gordon, professor at Saint John’s Cancer Institute, Santa Monica, California, said in an interview. “We are just now starting to see results from patients who get their second and even third round of screening.”

“Galleri is recommended to be used annually in addition to USPSTF [US Preventive Services Task Force]–recommended cancer screening tests, like mammography and colonoscopy,” she said.

This recommendation is based on a modeling study suggesting that annual screening would improve stage shift, diagnostic yield, and potentially mortality when compared to biennial screening, although biennial screening was still favorable compared with no screening, she explained.
 

Early Real-World Evidence of Repeat Testing

Among the cohort of 5,794 individuals who received repeat testing, 26 received a positive cancer signal on their second test, yielding a cancer signal detection rate of 0.45% (95% CI: 0.31%-0.66%). The cancer signal detection rate was slightly higher in men. The rate was 0.50% (95% CI: 0.32%-0.81%; 17 of 3367) in men versus 0.37% (95% CI: 0.2%-0.7%; 9 of 2427) in women.

During her presentation, Dr. Gordon highlighted that the repeat testing signal detection rate was lower than the initial 0.95% rate (95% CI: 0.87-1.0; 510 of 53,744) seen in the previous larger cohort of patients who were retested at 1 year.

She acknowledged that the lower cancer signal detection rate of repeat testing may indicate some degree of ‘early adopter’ bias, where those who return for a second test are systematically different from the general screening population. This could suggest that broader population-level screening may yield different results, she continued.
 

Shift Toward Unscreened Cancers

The top cancer types identified in the second round of testing were lymphoid, head and neck, bladder/urothelial, colorectal, and anal cancers. Clinicians were able to confirm clinical outcomes in 12 of 26 cases, in which cancer signals were detected. Of those 12 cases, 8 individuals received a cancer diagnosis and 4 did not have cancer. The remaining 14 of 26 cases in which cancer signals were detected are still under investigation.

“We found a shift away from USPSTF screen-detected cancers, like breast, lung, and prostate, and relative increase in unscreened urinary, head and neck, and lymphoid cancers, with 75% of cancers being those without any screening guidelines,” Dr. Gordon said in an interview.

She added that patients who choose to retest may have different cancer rates for several reasons, including bias toward a population that is health conscious and adhered to all recommended cancer screening.

“So the shift toward unscreened cancers is not unexpected and highlights the value of Galleri,” she said, but also acknowledged that “continued monitoring is needed to see if this translates in a persistent finding over time and tests.”
 

Shift Toward Early-Stage Cancers

Staging information was available for five cases, and Dr. Gordon highlighted in her talk that four of these confirmed cancers were stage I, including cancers of the anus, head and neck, bladder, and lymphoma. The fifth confirmed cancer with staging information was stage IV ovarian cancer.

“It is still early, and the numbers are very small, but the detection of early-stage cancers with second annual testing is very encouraging as these are the cases where MCED testing could have the greatest impact in improving outcomes through earlier treatment,” Dr. Gordon told this publication.

During an interview after the talk, Kenneth L. Kehl, MD, MPH, echoed that data must be confirmed in larger cohorts.

“The shift toward earlier stage cancers that are less detectable by standard screening methods is an interesting result, but we need to be cautious since the numbers were relatively small, and we do not have data on cancers that were diagnosed among patients whose second MCED test was also negative,” said Dr. Kehl, a medical oncologist at Dana-Farber Cancer Institute, Boston.
 

MCED Results Could Help Direct Diagnostic Workup

The test’s ability to predict the organ of origin was highly accurate, correctly identifying the cancer type in all eight confirmed cases. Among the eight cases with a confirmed cancer diagnosis, the accuracy of the first prediction was 100%, and diagnoses included invasive cancers across multiple tissues and organs, including anus, colon, head and neck, urothelial tract, ovary, and the lymphatic system.

“The fact that the site of origin for 100% of confirmed cancers was accurately predicted with GRAIL’s CSO by Galleri test confirms the promise that this can guide workup when a cancer signal is detected,” Dr. Gordon noted in the interview.
 

Looking Ahead

Dr. Kehl, who was not involved in the MCED study, noted in an interview that “further data on test characteristics beyond positive predictive value, including the sensitivity, specificity, and negative predictive value, as well as demonstration of clinical benefit — ideally in a randomized trial — will likely be required for MCED testing to become a standard public health recommendation.”

He added that challenges associated with implementing annual screening with MCED tests include the risks of both false positives and false negatives as testing becomes more widely available.

“False positives cause anxiety and lead to additional testing that may carry its own risks, and we need to understand if potentially false negative tests will be associated with less uptake of established screening strategies,” Dr. Kehl said in an interview. However, he noted that serial testing could lead to more frequent diagnoses of early-stage cancers that may be less detectable by standard methods.

Dr. Gordon reported financial relationships with GRAIL LLC and Genetic Technologies Corporation. Dr. Kehl reported no relationships with entities whose primary business is producing, marketing, selling, reselling, or distributing healthcare products used by or on patients.

SAN DIEGO — A novel multicancer early detection (MCED) blood test has demonstrated promising real-world results in detecting new cancers, including several cases of early-stage disease.

This was the conclusion of recent data presented by Ora Karp Gordon, MD, MS, during a session at the American Association for Cancer Research annual meeting.

The MCED test, known as Galleri, was made clinically available in the United States in April 2021. Developed by GRAIL LLC, the test analyzes cell-free DNA in the blood using targeted methylation analysis and machine learning to detect the presence of a cancer signal and determine its organ of origin or cancer signal origin. The initial screening of over 53,000 individuals with the Galleri test detected a cancer signal in 1.1% of participants.

The new real-world analysis examines the outcomes of repeat MCED testing in 5,794 individuals.

The study looked at individuals who initially received a ‘no cancer signal detected’ result and then underwent a second Galleri test. Over 80% of participants received their follow-up test 10-18 months after the first, with a median interval between blood draws of 12.9 months.

“The repeat tests detect those cancer cases that have reached the detection threshold since their last MCED test, which should be less than one year of incidence,” Dr. Gordon, professor at Saint John’s Cancer Institute, Santa Monica, California, said in an interview. “We are just now starting to see results from patients who get their second and even third round of screening.”

“Galleri is recommended to be used annually in addition to USPSTF [US Preventive Services Task Force]–recommended cancer screening tests, like mammography and colonoscopy,” she said.

This recommendation is based on a modeling study suggesting that annual screening would improve stage shift, diagnostic yield, and potentially mortality when compared to biennial screening, although biennial screening was still favorable compared with no screening, she explained.
 

Early Real-World Evidence of Repeat Testing

Among the cohort of 5,794 individuals who received repeat testing, 26 received a positive cancer signal on their second test, yielding a cancer signal detection rate of 0.45% (95% CI: 0.31%-0.66%). The cancer signal detection rate was slightly higher in men. The rate was 0.50% (95% CI: 0.32%-0.81%; 17 of 3367) in men versus 0.37% (95% CI: 0.2%-0.7%; 9 of 2427) in women.

During her presentation, Dr. Gordon highlighted that the repeat testing signal detection rate was lower than the initial 0.95% rate (95% CI: 0.87-1.0; 510 of 53,744) seen in the previous larger cohort of patients who were retested at 1 year.

She acknowledged that the lower cancer signal detection rate of repeat testing may indicate some degree of ‘early adopter’ bias, where those who return for a second test are systematically different from the general screening population. This could suggest that broader population-level screening may yield different results, she continued.
 

Shift Toward Unscreened Cancers

The top cancer types identified in the second round of testing were lymphoid, head and neck, bladder/urothelial, colorectal, and anal cancers. Clinicians were able to confirm clinical outcomes in 12 of 26 cases, in which cancer signals were detected. Of those 12 cases, 8 individuals received a cancer diagnosis and 4 did not have cancer. The remaining 14 of 26 cases in which cancer signals were detected are still under investigation.

“We found a shift away from USPSTF screen-detected cancers, like breast, lung, and prostate, and relative increase in unscreened urinary, head and neck, and lymphoid cancers, with 75% of cancers being those without any screening guidelines,” Dr. Gordon said in an interview.

She added that patients who choose to retest may have different cancer rates for several reasons, including bias toward a population that is health conscious and adhered to all recommended cancer screening.

“So the shift toward unscreened cancers is not unexpected and highlights the value of Galleri,” she said, but also acknowledged that “continued monitoring is needed to see if this translates in a persistent finding over time and tests.”
 

Shift Toward Early-Stage Cancers

Staging information was available for five cases, and Dr. Gordon highlighted in her talk that four of these confirmed cancers were stage I, including cancers of the anus, head and neck, bladder, and lymphoma. The fifth confirmed cancer with staging information was stage IV ovarian cancer.

“It is still early, and the numbers are very small, but the detection of early-stage cancers with second annual testing is very encouraging as these are the cases where MCED testing could have the greatest impact in improving outcomes through earlier treatment,” Dr. Gordon told this publication.

During an interview after the talk, Kenneth L. Kehl, MD, MPH, echoed that data must be confirmed in larger cohorts.

“The shift toward earlier stage cancers that are less detectable by standard screening methods is an interesting result, but we need to be cautious since the numbers were relatively small, and we do not have data on cancers that were diagnosed among patients whose second MCED test was also negative,” said Dr. Kehl, a medical oncologist at Dana-Farber Cancer Institute, Boston.
 

MCED Results Could Help Direct Diagnostic Workup

The test’s ability to predict the organ of origin was highly accurate, correctly identifying the cancer type in all eight confirmed cases. Among the eight cases with a confirmed cancer diagnosis, the accuracy of the first prediction was 100%, and diagnoses included invasive cancers across multiple tissues and organs, including anus, colon, head and neck, urothelial tract, ovary, and the lymphatic system.

“The fact that the site of origin for 100% of confirmed cancers was accurately predicted with GRAIL’s CSO by Galleri test confirms the promise that this can guide workup when a cancer signal is detected,” Dr. Gordon noted in the interview.
 

Looking Ahead

Dr. Kehl, who was not involved in the MCED study, noted in an interview that “further data on test characteristics beyond positive predictive value, including the sensitivity, specificity, and negative predictive value, as well as demonstration of clinical benefit — ideally in a randomized trial — will likely be required for MCED testing to become a standard public health recommendation.”

He added that challenges associated with implementing annual screening with MCED tests include the risks of both false positives and false negatives as testing becomes more widely available.

“False positives cause anxiety and lead to additional testing that may carry its own risks, and we need to understand if potentially false negative tests will be associated with less uptake of established screening strategies,” Dr. Kehl said in an interview. However, he noted that serial testing could lead to more frequent diagnoses of early-stage cancers that may be less detectable by standard methods.

Dr. Gordon reported financial relationships with GRAIL LLC and Genetic Technologies Corporation. Dr. Kehl reported no relationships with entities whose primary business is producing, marketing, selling, reselling, or distributing healthcare products used by or on patients.