GRAIL gets 7‑2 FDA panel backing for Galleri cancer test
Advisers voted 10 to 0 on safety and 6 to 4 on effectiveness; the FDA has not set a date for its final decision.
Theo Marchetti
The U.S. Food and Drug Administration's Molecular and Clinical Genetics Panel recommended on Sept. 23 that the benefits of the Galleri multi-cancer blood test outweigh its risks for the proposed screening population, STAT reported from the meeting. GRAIL, Inc. NASDAQGRAL received a 7-to-2 vote on that question, with one abstention, and still needs the FDA's own approval.
The agency will continue reviewing GRAIL's premarket approval application after the recommendation. Its advisory committee notice says panel advice is nonbinding and gives no date for a final FDA decision. The notice identifies the hearing docket as FDA-2026-N-8004 and says public comments closed Sept. 16.
Advisers also voted 10 to 0 that there was reasonable assurance Galleri is safe and 6 to 4 that there was reasonable assurance it is effective, according to STAT's account. Those were separate questions about the proposed indication, rather than votes to grant marketing approval.
GRAIL submitted its application on Jan. 29. The company said in its Aug. 7 release that the submission includes one-year follow-up on 25,490 consented participants in PATHFINDER 2 and data from more than 70,000 participants in the NHS-Galleri trial's first screening round. It also includes an analysis comparing the versions used in those studies with the updated version submitted for approval.
The Proposed Use Starts At Age 50
The FDA's voting document describes Galleri as a prescription-only test for cancer-specific methylation patterns in cell-free DNA from blood. GRAIL proposes to screen adults aged 50 or older for multiple types of cancer and predict where a detected signal may have originated.
A detected signal would lead to a diagnostic workup by a qualified health professional under the proposed indication. The test would supplement recommended screening for individual cancers, rather than replace those procedures. The limit on a negative result appears in the indication considered by the panel:
"A test result of No Cancer Signal Detected does not rule out the presence of cancer, and individuals should continue with guideline-recommended single-cancer screening tests," the proposed indication says.
In its briefing for the Sept. 23 panel, FDA staff framed the remaining question as whether the two pivotal studies showed probable benefits that outweigh probable risks for the intended screening group. The staff summary identifies PATHFINDER 2 and NHS-Galleri as the pivotal studies behind the premarket approval application.
The panel considered safety, effectiveness and benefit-risk under the indication GRAIL proposed for adults aged 50 or older. The FDA's own decision will determine whether that application is approved and what use, if any, the agency authorizes.
Read more: GRAIL's Galleri FDA staff briefing documents
The Sept. 23 votes now go to the FDA for its decision on GRAIL's application. The agency has not announced when that decision will be made.
