GRAIL has submitted the final module of its FDA Premarket Approval (PMA) application for the Galleri® multi-cancer early detection (MCED) blood test, moving the test one step closer to potential regulatory approval and broader clinical adoption in the U.S.
The PMA submission is anchored in data from two of the largest MCED studies to date: the PATHFINDER 2 U.S. registrational study and the NHS-Galleri randomized controlled trial in England. Together, these trials evaluate Galleri’s safety, performance, and real-world diagnostic pathways when used alongside standard cancer screening.