GRAIL Announces FDA Advisory Committee Review Of Galleri Multi-Cancer Early Detection Test

GRAIL said the U.S. FDA’s Molecular and Clinical Genetics Panel will meet on September 23, 2026 to review its Premarket Approval application for Galleri, its multi-cancer early detection test. The scheduled FDA advisory review is a constructive regulatory milestone for the program, but it is not yet a decision.

Analysis

GRAIL said the U.S. FDA’s Molecular and Clinical Genetics Panel will meet on September 23, 2026 to review its Premarket Approval application for Galleri, its multi-cancer early detection test. The scheduled FDA advisory review is a constructive regulatory milestone for the program, but it is not yet a decision.