GRAIL Submits FDA PMA for Galleri Multi-Cancer Early Detection Test

Key Takeaways GRAIL submitted the final PMA module to the FDA for its Galleri multi-cancer early detection blood test.The Galleri test holds FDA Breakthrough status, backed by U.S. PATHFINDER 2 results and the NHS-Galleri trial.The PMA includes data from 25,490 participants in PATHFINDER 2 and the first round of the NHS-Galleri trial.GRAIL, Inc. (GRAL) announced the submission of the final module of its premarket approval application to the FDA for the Galleri multi-cancer early detection (MCED) test. The F ...