On Oct. 4, 2024, Exact Sciences announced the U.S. Food and Drug Administration (FDA) had approved the Cologuard Plus™ test, the company’s next generation multitarget stool DNA test. The Cologuard Plus test was approved for adults ages 45 and older who are average risk for colorectal cancer (CRC).

Developed in collaboration with Mayo Clinic, the Cologuard Plus test features novel biomarkers and improved laboratory processes. 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.

CRC is often considered the most preventable, yet least prevented form of cancer. It remains the second deadliest cancer in the United States.