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Mayo Clinic to Offer Exact Sciences' Non-Invasive Colorectal Cancer Screening Test

NEW YORK (GenomeWeb) – Mayo Clinic will be the first health system to offer Exact Sciences' stool DNA-based colorectal cancer screening test, called Cologuard, the company said today.

Patients' primary care physicians at Mayo Clinic will be able to order the test, which earlier this month received approval from the US Food and Drug Administration. Simultaneously, the Centers for Medicare & Medicaid Services issued a national coverage determination proposing to reimburse the test once every three years for asymptomatic Medicare beneficiaries between ages 50 and 85 years who are at average risk for developing colorectal cancer.

Cologuard gauges DNA and blood biomarkers and determines whether a patient has pre-cancerous polyps or cancer. Once a doctor orders the test, Exact mails a sample collection kit to the patient's home, which he or she can then mail back to Exact for analysis. The turnaround time for test results is around two weeks. If the result is positive, then the patient will need to receive a colonoscopy for further analysis.

The non-invasive test was co-developed by Exact and Mayo as part of an exclusive collaboration. Mayo's David Ahlquist co-invented technology underlying Cologuard and licensed it to Exact. Under the licensing deal, Mayo and Ahlquist will share the equity and royalties from Cologuard.

According to Mayo, it will use revenues from this deal to support its "not-for-profit mission in patient care, education, and research."

The test is list priced just under $600. Exact Sciences CEO Kevin Conroy told PGx Reporter last week that the firm has proposed a discounted price to CMS of $502, and is expecting a decision with regard to pricing in August or September.