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Exact Sciences' Cologuard Now Recommended in ACS Guidelines

NEW YORK (GenomeWeb) — Exact Sciences today announced that the American Cancer Society's national guidelines on colorectal cancer prevention and early detection have been updated to reflect the commercial availability of the company's Cologuard cancer screening test.

Cologuard detects cancer-associated mutations and blood biomarkers in stool samples and has been shown to identify 92 percent of colorectal cancers in average risk patients with 87 percent specificity using only a single sample.

In August, Exact Sciences received simultaneous approval from the US Food and Drug Administration for Cologuard and a national coverage determination by the US Centers for Medicare & Medicaid Services 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.

In October, CMS issued a final National Coverage Determination for Cologuard, agreeing with the company's proposal to reimburse testing at $502.

According to Exact Sciences, the new ACS guidelines also reflect CMS's coverage determination and describe how patients can access Cologuard, including instructions on collecting and sending samples for testing.

"Colorectal cancer remains the second-leading cancer killer in the US due to low screening rates. These guidelines provide people with important information on the screening options available to them," Kevin Conroy, president, chairman and CEO of Exact Sciences, said in a statement.