GRAIL presses on with Galleri test despite missed primary endpoint in pivotal study Where GRAIL sees signals of benefit in the subgroups, screening experts see signs of overdiagnosis

The Galleri MCD vote: What FDA asked its advisors to ignore

In this episode of The Cancer Letter Podcast, Paul Goldberg, editor and publisher of The Cancer Letter, Jacquelyn Cobb, managing editor, discuss the Sept. 23 meeting of the FDA Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee, during which the panel voted in favor of Galleri, the multi-cancer detection test from GRAIL Inc., to become the first multi-cancer detection test to receive regulatory approval.

September 30, 2026

News Analysis Regulatory News

FDA advisory committee votes in favor of Galleri approval, but calls for removal of “early” detection claims
Clinical benefit will not be considered for approval, FDA says

The FDA Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee voted in favor of Galleri to become the first multi-cancer detection test to receive regulatory approval.

September 25, 2026

Vol.52 No.35

By Jacquelyn Cobb and Sara Willa Ernst

Drugs & Targets

FDA advisory committee to vote on GRAIL’s multi-cancer detection test, Galleri

FDA announced a forthcoming hybrid meeting of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee on Sept. 23 to discuss, make recommendations, and vote on information regarding the premarket approval application for the Galleri test sponsored by GRAIL, Inc.

August 14, 2026

Vol.52 No.32

Clinical Trials & Tribulations

What NHS-Galleri taught us—and what it didn’t

On May 30, GRAIL reported the full results of the NHS-Galleri trial in an oral presentation at the ASCO Annual Meeting.

June 18, 2026

Vol.52 No.24

By Scott D. Ramsey and Ruth Etzioni

Clinical Trials & Tribulations

The NHS-Galleri trial has and will continue to provide critical insights to refine future MCED studies

The NHS-Galleri trial presented at ASCO was the largest, prospective, randomized trial of a multicancer early detection test (MCED) to date. The study enrolled approximately 143,000 asymptomatic adults (ages 50-77) and was the first of its kind to assess clinical utility of an MCED test for cancer screening.

June 18, 2026

Vol.52 No.24

By Bryan Bassig, Catherine R. Marinac, David M. Routman, Elizabeth K. O'Donnell, Jennifer Keating Litton, Karthik V. Giridhar, Kennedy Ng Yao Yi, Kurt Giles, Nima Nabavizadeh, Ora K. Gordon, Rebecca Kaltman and Shawn Kothari

Clinical Roundup

GRAIL reports full results from NHS-Galleri trial at ASCO

GRAIL Inc. presented more detailed results of the NHS-Galleri trial in an oral presentation at the 2026 American Society of Clinical Oncology annual meeting.

June 05, 2026

Vol.52 No.22

GRAIL presses on with Galleri test despite missed primary endpoint in pivotal study

Where GRAIL sees signals of benefit in the subgroups, screening experts see signs of overdiagnosis

YOU MAY BE INTERESTED IN

The Galleri MCD vote: What FDA asked its advisors to ignore

FDA advisory committee votes in favor of Galleri approval, but calls for removal of “early” detection claims
Clinical benefit will not be considered for approval, FDA says

FDA advisory committee to vote on GRAIL’s multi-cancer detection test, Galleri

What NHS-Galleri taught us—and what it didn’t

The NHS-Galleri trial has and will continue to provide critical insights to refine future MCED studies

GRAIL reports full results from NHS-Galleri trial at ASCO

Renew today!

Subscriber content

Never miss an issue!

Login

GRAIL presses on with Galleri test despite missed primary endpoint in pivotal study

Where GRAIL sees signals of benefit in the subgroups, screening experts see signs of overdiagnosis

YOU MAY BE INTERESTED IN

The Galleri MCD vote: What FDA asked its advisors to ignore

FDA advisory committee votes in favor of Galleri approval, but calls for removal of “early” detection claimsClinical benefit will not be considered for approval, FDA says

FDA advisory committee to vote on GRAIL’s multi-cancer detection test, Galleri

What NHS-Galleri taught us—and what it didn’t

The NHS-Galleri trial has and will continue to provide critical insights to refine future MCED studies

GRAIL reports full results from NHS-Galleri trial at ASCO

Never miss an issue!

Login

FDA advisory committee votes in favor of Galleri approval, but calls for removal of “early” detection claims
Clinical benefit will not be considered for approval, FDA says