On Friday, the FDA approved Exact Sciences Corp.’s (NASDAQ:EXAS) Cologuard Plus test, the company’s next-generation multi-target stool DNA test.
The Cologuard Plus test is now approved for adults ages 45 and older who are at average risk for colorectal cancer (CRC).
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 ...
