October 14, 2019 -- Exact Sciences is working with the Mayo Clinic in Rochester, MN, on a 150,000-patient, long-term, real-world study -- dubbed Voyage -- of its Cologuard noninvasive test for colon cancer.
Cologuard tests stool for 10 DNA markers, as well as for blood. The Mayo Clinic will lead the prospective, observational study, which will enroll patients nationwide who have a clinical order for the test and will track the use of health services and outcomes -- including mortality -- over the course of seven years. Outcomes data from real-world settings can be useful for boosting uptake with providers and reimbursement with payors. In a statement, the company said the data will build the evidence base and support continued adoption of the product.
Cologuard was initially cleared in 2014 by the U.S. Food and Drug Administration (FDA) for people age 50 years and older. The approval was supported by a prospective validation study of 10,000 people. In September, the FDA expanded the clearance to include use in people 45 years and older who are at average risk for colon cancer.