Grail's Galleri blood test receives positive FDA advisory panel vote, moving closer to approval

Grail's multi‑cancer blood test Galleri earned a favorable recommendation from the FDA's medical devices advisory committee, bringing the test one step nearer to U.S. market clearance.

The panel voted 7‑2 in favor of the test's intended use for adults aged 50 and older, with one abstention. Safety received unanimous support, while efficacy was more contested, resulting in a 6‑4 vote on whether the data sufficiently demonstrated the test's effectiveness.

The advisory opinion does not guarantee final approval, but it signals strong regulatory confidence and may influence the FDA's upcoming decision on pre‑market clearance for Galleri.