GRAIL, Inc., a healthcare company focused on early cancer detection, announced progress in the regulatory review process for its Galleri® multi-cancer early detection (MCED) test. The company is in the midst of a Premarket Approval (PMA) submission to the U.S. Food and Drug Administration (FDA) under a Breakthrough Device Designation. The submission is modular, with GRAIL anticipating completion in the first half of 2026. The PATHFINDER 2 study results, demonstrating enhanced cancer detection and safety, will be part of this application. Additionally, bridging analyses comparing different versions of Galleri will be included. There were no safety concerns reported in the study, further supporting the test's reliability.
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