NasdaqGS:GRALBiotechs
Did FDA’s Galleri PMA Panel Date Just Shift GRAIL's (GRAL) Multi‑Cancer Screening Narrative?
GRAIL announced that the FDA’s Molecular and Clinical Genetics Panel will meet on September 23, 2026, to review its Premarket Approval application for the Galleri multi-cancer early detection blood test, which uses methylation patterns and artificial intelligence to detect cancer signals and predict their origin alongside existing screening methods.
The PMA filing leans on extensive data from the PATHFINDER 2 study of 25,490 U.S. participants and over 70,000 participants from the NHS-Galleri...