The FDA’s approval was based on findings from the Blue-C study, one of the largest prospective, head-to-head studies ever conducted in CRC screening, according to an Oct. 4 press release.
Among the 19,000 study participants, the Cologuard Plus test demonstrated 95% overall cancer sensitivity and 43% sensitivity for advanced precancerous lesions at 94% specificity.
The Cologuard Plus test also outperformed an independent fecal immunochemical test for overall CRC sensitivity, treatable-stage CRC sensitivity, high-grade dysplasia sensitivity and advanced precancerous lesion sensitivity.
The traditional Cologuard test has been used more than 17 million times. The Cologuard Plus test is expected to launch in 2025 and is anticipated to be covered by Medicare.
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.