FDA to review Grail's Galleri multi-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 blood test. The Molecular and Clinical Genetics Panel will convene to evaluate whether the test, which aims to screen for more than 50 types of cancer, can effectively detect signals without excessive false positives or negatives.

Galleri is a multi-cancer early detection (MCED) test that analyzes molecular signals shed by tumors into the bloodstream. While currently available as a laboratory-developed test, it lacks formal FDA approval. The review follows a recent three-year UK trial that indicated the test did not significantly improve early detection or reduce late-stage diagnoses compared to standard care in asymptomatic adults.

The upcoming regulatory review is critical for the future of MCED technology. A January U.S. congressional funding bill established a pathway for Medicare coverage of FDA-approved MCED tests for individuals aged 50 to 65 starting in 2029, provided clinical benefit is demonstrated.