FDA Molecular and Clinical Genetics Advisory Committee endorses Galleri, recommending approval for multi-cancer early detection

GRAIL/Galleri

On September 23, 2026, the FDA's Medical Devices Advisory Committee voted to recommend approval of Galleri. The panel concluded that the test's benefits in detecting cancers early—when they are more treatable—outweigh the risks, including false positives and the need for further diagnostic workup. Full FDA approval is expected before the end of 2026.