Exact Sciences (ES; Madison, Wisconsin) is closing in on a successful parallel review effort, announcing Aug. 12 it had won FDA approval of the firm's Cologuard diagnostic, the same day the Centers for Medicare & Medicaid Services announced a coverage proposal for the test for screening of colorectal cancer in asymptomatic patients of average risk aged 50-85. The company used a clinical trial of 10,000 patients to bolster the application for both agencies, and Kevin Conroy, the company's president/CEO, explained CMS's motive for covering the test. He noted that Medicare is already paying for the vast majority of colorectal cancer treatment costs, and "the way to reduce those costs is to detect early." Read More
