FDA review of Grail Galleri cancer blood test

The U.S. Food and Drug Administration (FDA) has scheduled an advisory committee meeting for September 23, 2026, to review the premarket approval application for Grail Inc.’s Galleri multi-cancer early detection (MCED) blood test. The Molecular and Clinical Genetics Panel will evaluate the test’s ability to detect signals for over 50 types of cancer without excessive false results.

While the Galleri test is currently available as a laboratory-developed test, it lacks formal FDA approval. Previous clinical trials in the UK suggested the test did not significantly improve early detection or reduce late-stage diagnoses in asymptomatic adults compared to standard care. However, Grail management has noted “favorable trends in specific deadly cancer types.”

Following the news of the scheduled FDA meeting, Grail’s stock rose 15.8% in August. The company is currently working to demonstrate the cost-benefit of the technology to medical insurers to encourage adoption. Regulatory approval is a key milestone, as a U.S. congressional funding bill has established a pathway for Medicare coverage of FDA-approved MCED tests for certain age groups starting in 2029, provided clinical benefit is demonstrated.