FDA Panel Backs Guardant's Blood Test for Colon Cancer
TL;DR Summary
An FDA advisory panel has recommended the approval of Guardant Health's blood test, Shield, for detecting colorectal cancer. If approved, it would be the second blood-based test for this cancer in the U.S. after Epi proColon. While Shield is seen as more convenient than colonoscopy, concerns were raised about its lower accuracy, particularly in detecting pre-cancerous tumors. The test detected 83% of colorectal cancers in studies, compared to 92.3% for Exact Sciences' Cologuard.
- FDA panel recommends approval of a blood test for colon cancer NBC News
- 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.com
- Blood test to detect colon cancer could move a step closer to FDA approval in the US CNN
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