FDA Panel Backs Guardant's Blood Test for Colon Cancer Screening
TL;DR Summary
An FDA advisory panel has endorsed the safety and effectiveness of Guardant Health's new blood test, Shield, for screening colon and rectal cancers, despite its limitations compared to colonoscopies. The test detected 83% of colorectal cancers but only 13% of dangerous polyps, whereas colonoscopies find 95% of such polyps. The panel hopes the blood test will increase screening rates, though it must be followed by a colonoscopy if abnormalities are found.
- F.D.A. Panel Endorses Safety of Colon-Cancer Blood Test The New York Times
- Guardant Health's colorectal cancer screening blood test gets thumbs-up from FDA panel Fierce Biotech
- U.S. FDA advisers back approval for Guardant's blood-based cancer test Reuters
- FDA Advisory Committee Panel Strongly Recommends Approval of Shield™ Blood Test for Colorectal Cancer Screening as a Primary Non-Invasive Screening Option Yahoo Finance
- Blood test to detect colon cancer could move a step closer to FDA approval in the US CNN
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