GH - FDA Advisory Panel Supports Approval Of Guardant Health's Blood Test For Colorectal Cancer Screening | Benzinga
Thursday, the Molecular and Clinical Genetics Panel of FDA’s Medical Devices Advisory Committee recommended FDA approval of Guardant Health Inc’s (NASDAQ:GH) Shield blood test for colorectal cancer (CRC) screening.
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 FDA is expected to decide whether to approve Shield later this year.
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.
The panel’s recommendation is based on Guardant’s premarket approval application for Shield, including the results of the pivotal ECLIPSE study.
Results showed ...