Grail submits FDA premarket approval appplication for Galleri

GRAIL (GRAL) “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.”