Exact Sciences Corp., a provider of cancer screening and diagnostic tests, announced positive top-line results from the 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.
“Cologuard is a groundbreaking innovation in non-invasive cancer detection. Next-generation Cologuard will set a new performance standard,” says Kevin Conroy, chairman and CEO of Exact Sciences. “We are harnessing deep scientific insights, advanced technology, and over a decade of research and development to detect colorectal cancer with greater sensitivity and significantly improve the false positive rate. Once approved, next-generation Cologuard will meaningfully enhance the patient experience, and it comes at a critical time – when there are 60 million Americans not up to date with screening.”
About the BLUE-C Study
BLUE-C is a multi-center, prospective study (NCT04144738) of more than 20,000 adults 40 years of age and older. The trial was designed to evaluate the performance of next-generation Cologuard (multi-target stool DNA or mt-sDNA). Using colonoscopy as a reference method, the robust study design directly compares multiple screening tests, including next-generation Cologuard and a fecal immunochemical test (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.
“Accurate and early detection of colorectal cancer and precancerous lesions is critical for reducing incidence and preventing deaths from this disease,” says Thomas F. Imperiale, MD, Professor of Medicine at the Indiana University School of Medicine, research scientist at the Regenstrief Institute, and principal investigator for BLUE-C. “The results from this large study of a representative population provide affirmation that Exact Sciences continues at the forefront of non-invasive screening. These new results suggest improved performance of an mt-sDNA test, strengthening the case for molecular stool-based testing.”
About Next-generation Cologuard Test
Developed in partnership with Mayo Clinic, next-generation Cologuard features novel biomarkers and improved laboratory processes. It also incorporates enhanced sample stability components to provide patients more time to return their sample to Exact Sciences’ lab and increase the valid result rate.
Nearly a decade later, Cologuard has been used to screen for colorectal cancer more than 12 million times.
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.
Featured Image: Madison Haag, clinical laboratory specialist, loads samples for one step of the Cologuard testing process at one of Exact Sciences’ Madison labs. Photo: Exact Sciences
