GRAIL, Inc. has submitted the final module of its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the Galleri® multi-cancer early detection (MCED) test. The Galleri test, which was designated as a Breakthrough Device by the FDA in 2018, aims to improve early cancer detection. The PMA submission is based on test performance and safety data from 25,490 participants in the US-based PATHFINDER 2 study and the first year of the NHS-Galleri trial. A bridging analysis comparing different versions of the Galleri test was also included to support the application.

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