July 29, 2024—Guardant Health announced FDA approval of the company’s Shield blood test for colorectal cancer screening in adults who are 45 and older are at average risk for the disease. It is the first blood test to be approved by the FDA as a primary screening option for CRC and that meets performance requirements for Medicare coverage.
The FDA approval was based on the results of ECLIPSE, a registrational study that evaluated the performance of the test for detecting CRC in average-risk adults and included more than 20,000 patients. The study was conducted at more than 200 clinical trial sites in rural and urban communities across 37 states. Results from the study showed that Shield demonstrated 83 percent sensitivity for the detection of CRC, with 90 percent specificity for advanced neoplasia.
Shield is available for eligible people by prescription through a doctor or other health care professional and is expected to be covered for eligible Medicare beneficiaries.