NEW YORK – Exact Sciences announced on Friday that its next-generation Cologuard Plus test has received approval from the US Food and Drug Administration.
The multitarget stool DNA test was approved for use in adults ages 45 and older who are at average risk for colorectal cancer. The approval was based on findings from Exact's BLUE-C study, where the test showed 95 percent overall sensitivity, 43 percent sensitivity for advanced precancerous lesions, and 94 percent specificity, Exact Sciences said in a statement.
The test was developed in collaboration with the Mayo Clinic and features novel biomarkers and improved laboratory processes, the company added. It also includes enhanced sample stability components to allow patients more time to return their sample to the Exact Sciences lab and increase the valid result rate.
The Madison, Wisconsin-based firm said it expects to launch Cologuard Plus with Medicare coverage and US Preventive Services Task Force guideline inclusion in 2025.
"Cologuard Plus sets a new performance standard in noninvasive colorectal cancer screening for patients," Exact Sciences Chairman and CEO Kevin Conroy said in a statement. "Cologuard Plus detects cancers and precancerous polyps with even greater sensitivity than Cologuard while reducing false positives by more than 30 percent. This breakthrough comes at a critical time, when 60 million Americans are not up to date with screening."