GRAIL Submits Final PMA Application for Galleri Multi-Cancer Early Detection Test
GRAIL "announced the submission of the final module of the Premarket Approval application to the U.S. Food and Drug Administration for its Galleri(R) multi-cancer early detection test. The FDA designated the test as a Breakthrough Device in 2018. The PMA submission is focused on the test performance and safety results from 25,490 consented participants in the US-based PATHFINDER 2 study with one year of follow up and from the prevalent screening round (first year) of the NHS-Galleri trial, the largest, and only, randomized, controlled trial of any MCED test in an intended use population. The submission is also supported by a bridging analysis to compare performance of the version of Galleri used in the PATHFINDER 2 study and the NHS-Galleri trial to the updated PMA version that has been submitted to the FDA for premarket approval."
