On June 20, 2023 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, reported positive top-line results from the pivotal BLUE-C study (Press release, Exact Sciences, JUN 20, 2023, View Source [SID1234632793]). The results show that next-generation Cologuard met all study endpoints and improved every top-line metric, including a 30 percent lower false positive rate, when compared to DeeP-C, the FDA registrational trial for Cologuard.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Madison Haag, clinical laboratory specialist, loads samples for one step of the Cologuard testing process at one of Exact Sciences’ Madison labs.
"Cologuard is a groundbreaking innovation in non-invasive cancer detection. Next-generation Cologuard will set a new performance standard," said 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," said 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
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.
Cologuard revolutionized colorectal cancer screening by providing a convenient and accurate testing option for those at average risk. 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.
About Cologuard
Results from Exact Sciences’ prospective, 90-site, point-in-time, 10,000-patient pivotal trial, DeeP-C, were published in the New England Journal of Medicine in March 2014. The Cologuard test is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2021) and National Comprehensive Cancer Network (2023). The Cologuard test is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use the Cologuard test if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. The Cologuard test is not a replacement for colonoscopy in high-risk patients. The Cologuard test performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. The Cologuard test performance in repeat testing has not been evaluated.
The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. Medicare and most major insurers cover the Cologuard test. For more information about the Cologuard test, visit cologuardtest.com. Rx only.