StoryRegulatory
FDA approves Guardant Health's Shield blood test as the first blood-based colorectal cancer screening option
The FDA approved Shield as the first blood test for primary colorectal cancer screening in average-risk adults aged 45+. The approval was based on the ECLIPSE trial, which showed 83% sensitivity for detecting colorectal cancer while avoiding colonoscopy's complexity and discomfort. Patients with positive Shield results still need colonoscopy for confirmation.