Exact Sciences to Release Full BLUE-C Study Results at ACG
Exact Sciences Corp. is set to present data on its next-generation Cologuard® from the BLUE-C pivotal trial during the American College of Gastroenterology (ACG) Annual Meeting, scheduled for October 20-25, 2023, in Vancouver, Canada. The presentation from the study will be on October 24 at 3:35 pm.
In June the company released the topline results from the BLUE-C Study, a multi-center, prospective trial involving over 20,000 adults aged 40 and older, aimed to assess the performance of next-generation Cologuard (multi-target stool DNA or mt-sDNA) in comparison to colonoscopy and a fecal immunochemical test (FIT) as reference methods. The test demonstrated improved sensitivity for both cancer and pre-cancers along with higher specificity. Cancer sensitivity was 94% vs. 92% in the DEEP-C study, and cancer specificity was 91% vs. 87% in the DEEP-C study. According to a study conducted by the United States Preventive Services Task Force (USPSTF) colonoscopy, considered the gold standard for colon cancer detection, has a sensitivity of 73-98% and a specificity of 89-91%. Consequently, the new data would put Cologuard on par with colonoscopy for colon cancer detection.
The next-generation Cologuard test was developed in collaboration with Mayo Clinic and was designed to provide better clinical performance. The test utilizes new biomarkers and enhanced laboratory processes to improve its accuracry. Additionally, this advanced version incorporates enhanced sample stability components, extending the time they have to return their samples to Exact Sciences’ laboratory. Currently, the company is in the final stages of the FDA submission process for the test, with plans to make this advanced screening tool available to patients in early 2025 upon FDA approval.
Paul Limburg, MD, MPH, AGAF, Chief Medical Officer for Screening at Exact Sciences, expressed excitement about sharing results from the pivotal BLUE-C study. He emphasized the importance of continuous innovation, particularly in the context of the 60 million Americans who are not up to date with colorectal cancer screening.