Exact Sciences has received U.S. Food and Drug Administration (FDA) approval for its next-generation Cologuard Plus colorectal cancer (CRC) screening test.
The Cologuard Plus multitarget stool DNA test was approved for adults ages 45 and older who are at average risk for CRC.
According to a statement from Exact Sciences, the FDA approval was based on findings from the BLUE-C study (NCT04144738), a multicenter, prospective study of more than 20,000 adults 40 and older. The trial was designed to evaluate the performance of the Cologuard Plus test (multitarget stool DNA or mt-sDNA) and Exact Sciences’ blood-based CRC screening test.
In the study, the Cologuard Plus test demonstrated 95% overall cancer sensitivity and 43% sensitivity for advanced precancerous lesions at 94% specificity, with no findings on colonoscopy among the nearly-19,000 participants in the average-risk group. The findings also showed that Cologuard Plus significantly outperformed an independent fecal immunochemical test for overall CRC sensitivity, treatable-stage (stages I-III) CRC sensitivity, high-grade dysplasia sensitivity, and advanced precancerous lesion sensitivity.
The Cologuard Plus test, which is expected to launch in 2025, will be supported by Exact Sciences’ ExactNexus technology platform. The test is anticipated to be covered by Medicare, and included in quality measures and in the U.S. Preventive Services Taskforce (USPSTF) guidelines, the firm noted.
