Overview
- Grail has asked the FDA for premarket approval of Galleri and the agency has scheduled an outside advisory panel to review the company’s application and supporting data.
- The PMA relies mainly on the U.S. PATHFINDER 2 study of about 25,000 people and the large NHS-Galleri randomized trial, which produced mixed results for population-level early detection.
- NHS-Galleri’s full results showed no significant improvement in early detection overall but did report a 26% reduction in stage IV diagnoses for 12 cancers by the third screening round and a fourfold rise in cancers found when Galleri was added to standard screening.
- Galleri is already sold as a laboratory-developed test under CLIA rules and competing tests exist, but no MCED has full FDA approval yet, so payer coverage and routine clinical use remain uncertain.
- A recent U.S. congressional funding bill created a conditional Medicare coverage route for FDA-approved MCEDs beginning in 2029 that requires demonstrated clinical benefit, so the advisory panel’s view could shape both approval and who pays for the test.