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Guardant Health announces positive results from pivotal ECLIPSE study evaluating a blood test for the detection of colorectal cancer
- The test demonstrated 83% sensitivity for the detection of colorectal cancer with specificity of 90% - Results pave the way for first potential
About this update from Guardant Health, Inc.
[{"type":"text","content":"\n- The test demonstrated 83% sensitivity for the detection of colorectal cancer with specificity of 90%\n- Results pave the way for first potential FDA-approved and Medicare-reimbursed blood test for colorectal cancer screening\n- The company will host a webcast and conference call to discuss the results today at 5:00 p.m. ET, 2:00 p.m. PT\n\n PALO ALTO, Calif.--(BUSINESS WIRE)--\nGuardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today positive results from ECLIPSE (Evaluation of ctDNA LUNAR Assay In an Average Patient Screening Episode), an over 20,000 patient registrational study evaluating the performance of its blood test for detecting colorectal cancer (CRC) in average-risk adults.\n\nThe 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 (FDA) in the first quarter of 2023. These results exceed the performance criteria set forth by the Centers for Medicare & Medicaid Services (CMS) for reimbursement.1\n\nIn this study, two configurations of a multimodal blood-based screening test were evaluated independently - a cell-free DNA (cfDNA)-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.\n\nIn 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.2 This is in stark contrast with adherence rates ranging from 43%3 to 66%4 for other non-invasive stool tests. Screening rates remain stagnant and well below the Centers for Disease Control and Prevention’s goal of 80%.5 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.\n\n“Over 49 million eligible people in the ...