FDA advisers to weigh cancer blood test
Ella Jeffries / beckershospitalreview - The FDA’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee will meet Sept. 23 to discuss and vote on Grail’s premarket approval application for its Galleri blood test, according to a notice published Aug. 10 in the Federal R…
AI Summary: FDA advisors are set to review a multi-cancer early-detection blood test, weighing evidence on accuracy, clinical utility, and how to handle follow-up diagnostics. Regulators must decide whether the test meets approval standards for broad screening, balancing potential earlier cancer detection against risks of false positives, overdiagnosis, and costly downstream workups.