Exact Sciences announces results from BLUE-C study

Exact Sciences announced positive top-line results from the pivotal BLUE-C study. The results show that next-generation Cologuard met all study endpoints and improved every top-line metric, including a 30% lower false positive rate, when compared to DeeP-C, the FDA registrational trial for Cologuard. BLUE-C is a multi-center, prospective study of more than 20,000 adults 40 years of age and older. The trial was designed to evaluate the performance of next-generation Cologuard. Using colonoscopy as a reference method, the robust study design directly compares multiple screening tests, including next-generation Cologuard and a fecal immunochemical test, or FIT. Blood samples were also collected for later evaluation of a blood-based screening test being developed by Exact Sciences. BLUE-C is one of the largest colorectal cancer screening trials ever conducted, and the study population reflects the racial and ethnic makeup of the United States according to the 2020 census. In the coming months, Exact Sciences plans to release additional analyses of the BLUE-C data and complete its application to the FDA for approval of next-generation Cologuard.