Guardant Health reports ‘positive’ results from ECLIPSE study

Guardant Health announced positive results from ECLIPSE, an over 20,000 patient registrational study evaluating the performance of its blood test for detecting colorectal cancer in average-risk adults. The test demonstrated 83% sensitivity in detecting individuals with CRC. Specificity was 90% in both individuals without advanced neoplasia and in those who had a negative colonoscopy result. This test also demonstrated 13% sensitivity in detecting advanced adenomas. Based on these study results, Guardant Health plans to complete its premarket approval submission to the U.S. Food and Drug Administration n the first quarter of 2023. These results exceed the performance criteria set forth by the Centers for Medicare & Medicaid Services for reimbursement. In this study, two configurations of a multimodal blood-based screening test were evaluated independently – a cell-free DNA-only test and a cfDNA test with protein biomarkers. The announced results were derived from the cfDNA-only test, which outperformed the cfDNA test with protein biomarkers. In addition to the strong clinical performance, blood-based screening has been shown to significantly enhance adherence to CRC screening in a real-world setting. Among the initial 8,000 individuals for whom the test was ordered during a routine visit with their physician, 90% completed the test. This is in stark contrast with adherence rates ranging from 43% to 66% for other non-invasive stool tests. Screening rates remain stagnant and well below the Centers for Disease Control and Prevention’s goal of 80%. By providing accurate and convenient screening via a simple blood draw, the company’s blood-based screening test has the potential to significantly improve screening rates and help save lives.