Exact Sciences Wins U.S. Approval for Colon Cancer Test
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Exact Sciences Corp. won U.S. regulatory approval to sell the first noninvasive DNA screening test for colorectal cancer that patients can use at home.
The Food and Drug Administration cleared Cologuard, which screens stool samples for the presence of red blood cells and DNA mutations that may indicate the presence of cancer. Patients use Madison, Wisconsin-based Exact Sciences’ test at home and those who have positive results are advised to get a colonoscopy, which uses a small video camera on the end of a thin tube to view the colon, the FDA said in a statement.