FDA Decision Expands Market for Exact Sciences’ Cologuard Test
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FDA Decision Expands Market for Exact Sciences’ Cologuard Test

FDA Decision Expands Market for Exact Sciences’ Cologuard Test

Exact Sciences has taken another step toward ramping up sales of its flagship product, a non-invasive, stool-based screening test for colorectal cancer. The FDA has approved the test, Cologuard, for eligible, average-risk patients ages 45 and older, which expands the market that Madison, WI-based Exact can address with its product.

The Monday decision by the FDA is not a major surprise. In May 2018, the American Cancer Society released new guidelines that lowered the recommended age at which patients should first get screened for colorectal cancer from 50 to 45. Up to this point, Exact has primarily focused on marketing Cologuard to patients who had already turned 50, or were about to.

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