MedPage Today May 24, 2024
— But advisors urge strong labeling emphasizing Shield test’s low sensitivity for advanced adenomas
An FDA panel on Thursday endorsed a blood-based test for colorectal cancer (CRC) screening in adults 45 years and older at average risk for the disease, putting aside concerns over the test’s low sensitivity for precancerous lesions.
In a series of three votes on Guardant Health’s Shield test, the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee voted 8-1 in support of the test’s safety, 6-3 in support of its effectiveness, and 7-2 in support of the test’s benefit-risk profile.
Despite the positive votes, the panel as a whole still had concerns about Shield’s ability to detect early-stage CRC and advanced adenomas, and...
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