Novel Blood Test for CRC Screening Receives FDA Approval: Daily Dose

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Last week, we reported on the US Food and Drug Administration (FDA) approval of the Shield blood test (Guardant Health) for colorectal cancer (CRC) screening in adults 45 years and older at average risk for the disease.

The approval

Shield is the first blood test to be approved as a primary screening option for CRC in line with other noninvasive screening options recommended in screening guidelines, and the first blood test to meet the performance requirements to be covered under Medicare. During a routine office visit, primary care physicians can have patients complete a Shield blood test with a simple blood draw to avoid the preparation, dietary changes, time, and discomfort associated with a colonoscopy or stool-based tests.

The decision comes after the Molecular and Clinical Genetics Panel of the FDA’s Medical Devices Advisory Committee met in May 2024 and strongly voted in favor of Shield’s approval. The FDA based its approval on data from the ECLIPSE trial, a prospective registrational that compared the blood test against screening colonoscopy in average-risk adults aged 45 to 84 years from more than 200 clinical trial sites across the US. Results showed that the blood test demonstrated 83% sensitivity for the detection of CRC, 90% specificity for advanced neoplasia, and 13% sensitivity for advanced precancerous lesions.

The Shield blood test will be available for all eligible patients and Medicare beneficiaries, with expansions into commercial insurance coverage following inclusion of the test in future guidelines from the American Cancer Society and the US Preventive Services Task Force.

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