FDA Approves First Colorectal Cancer Blood Test

The FDA approved the Guardant Health, Inc. Shield, a test intended to screen for colorectal cancer (CRC) using blood collected in the Guardant Shield Blood Collection Kit. The test is used for CRC screening in individuals at average risk for the disease who are 45 years of age or older. Patients with positive test results should have a colonoscopy since the test is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals. Shield has limited detection (55%-65%) of Stage I colorectal cancer and does not detect 87% of precancerous lesions.

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