FDA Panel Votes on Grail’s Multicancer Test, Highlights Data Gaps Alicia Ault

https://www.medscape.com/viewarticle/fda-panel-votes-grails-multicancer-test-highlights-data-gaps-2026a1000zvy An FDA advisory panel said the benefits of Grail’s multicancer detection test outweigh its risks but acknowledged that there is no proof that the diagnostic can reduce mortality. In a series of votes, the FDA’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee agreed that Grail’s Galleri multicancer early detection (MCED) test was safe (10 yes, 0 no) and effective (6-4), and that the benefits outweighed the risks (7-2, with one abstention). While the votes on safety, effectiveness, and balance of risks and benefits “relate to the approvability of Galleri,” the committee did not explicitly vote on whether to approve the MCED test.