Exact Sciences announces FDA approval of Cologuard Plus test

Exact Sciences announced the U.S. Food and Drug Administration approved the Cologuard Plus test, the company’s next generation multitarget stool DNA test. The Cologuard Plus test is now approved for adults ages 45 and older who are average risk for colorectal cancer. FDA approval was based on findings from the pivotal BLUE-C study, one of the largest prospective, head-to-head studies ever conducted in CRC screening. Among the subset of nearly 19,000 average-risk participants, the Cologuard Plus test demonstrated 95% overall cancer sensitivity and 43% sensitivity for advanced precancerous lesions at 94% specificity with no findings on colonoscopy. Results from BLUE-C also show the Cologuard Plus test significantly outperformed an independent fecal immunochemical test for overall CRC sensitivity, treatable-stage CRC sensitivity, high-grade dysplasia sensitivity, and advanced precancerous lesion sensitivity.