Exact Sciences won Food and Drug Administration approval on Friday for an improved version of a stool-based screening test for colon cancer that should result in fewer cancer-free patients receiving unnecessary follow-up colonoscopies.
The FDA approved the test, Cologuard Plus, for adults 45 and up with an average risk of cancer based on results from a large clinical trial, dubbed Blue-C, which recruited more than 20,000 participants.
Earlier this year, Exact reported in the New England Journal of Medicine that the new test detected 94% of cancers and 43% of advanced precancers, abnormal cell growths that often precede disease. The company also reported that Cologuard Plus correctly returned a negative result in 91% of participants who didn’t have colon cancer or advanced precancer, a test feature known as specificity.
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