FDA AdCom recommends approval of Guardant Health’s Shield blood test

The company states: “Guardant Health announced the Molecular and Clinical Genetics Panel of the FDA’s Medical Devices Advisory Committee has strongly recommended FDA approval of the company’s Shield blood test for colorectal cancer screening in adults age 45 and older who are at average risk for the disease. The recommendation signals the advisory committee panel’s consensus on Shield’s safety and effectiveness with its proposed intended use, and their conclusion that its benefits as a primary non-invasive screening option outweigh any potential risks. The committee offers valuable perspective and non-binding recommendations for the FDA to factor in alongside other considerations during approval decisions. The FDA is expected to decide whether to approve Shield later this year. The advisory committee panel members voted on three questions regarding the use of Shield in patients who meet the criteria specified in the proposed indication. They voted 8 to 1 favorably that there is reasonable assurance Shield is safe, 6 to 3 favorably that there is reasonable assurance Shield is effective, and 7 to 2 favorably that the benefits of Shield outweigh its risks.”