AdComm votes in favor of new colorectal cancer screening test, but questions about serial testing and labeling remain


In May 2024, the FDA’s Molecular and Clinical Genetics Device panel voted 7-2 in favor of the approval of a new blood-based screening test for colorectal cancer, which would be the first blood-based test of this type. Discussions at the panel meeting highlighted questions about the role of screening tests and their place in the clinical workflow, labeling for screening indications, and the challenges of studying “repeat” tests.

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