GRAIL Announces FDA Advisory Committee Review Of Galleri Multi-Cancer Early Detection Test
GRAIL said the FDA Molecular and Clinical Genetics Panel will meet Sept. 23, 2026 to review its Premarket Approval application for Galleri, a multi-cancer early detection blood test. The submission cites PATHFINDER 2 (25,490 participants, one year) and NHS-Galleri (over 70,000). GRAIL says Galleri detects methylation patterns, with low false positives and accurate signal origin prediction.





