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NEWS
GRAIL Advances the Galleri® Registrational Clinical Trial Program
GRAIL (NASDAQ: GRAL) has announced significant progress in its clinical trials for the Galleri® multi-cancer early detection (MCED) test. The company has completed enrollment of over 35,000 participants in the PATHFINDER 2 study across North America and finished the final study visits for the NHS-Galleri trial with more than 140,000 participants in England. Results from the first 25,000 PATHFINDER 2 participants are expected in the second half of 2025, while final results from the NHS-Galleri trial are anticipated in 2026. These studies aim to expand GRAIL's clinical validation and performance evidence for the Galleri test, with a focus on diverse participant populations. The data will support GRAIL's premarket approval application to the FDA, which is currently in process under a Breakthrough Device Designation.
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