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FDA Approves Guardant Health's Shield™ Blood Test for Colorectal Cancer; Shares Rise 7%
Jul 29, 2024, 03:00 PM
The U.S. Food and Drug Administration (FDA) has approved Guardant Health's Shield™ blood test as a primary screening option for colorectal cancer. This approval marks a significant advancement in cancer detection, particularly for individuals aged 45 and older who are at average risk. The test, which detects cancer in the colon or rectum, is expected to increase screening rates, especially among those who may avoid colonoscopies. Guardant Health's shares rose 7% following the announcement, with a 9.1% increase in premarket trading and a 16% rise in premarket trading on Monday. The approval also paves the way for Medicare reimbursement, potentially making the test more accessible. The FDA's decision was based on data from the ECLIPSE trial. Experts hope that the new test will lead to earlier detection and treatment of colorectal cancer, although it is not a perfect alternative to colonoscopies.
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