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Exact Sciences' Cologuard wins US FDA nod for expanded use in colorectal cancer

Exact Sciences Corp.'s Cologuard was approved by the U.S. Food and Drug Administration to detect colon cancer in patients ages 45 and older.

Cologuard is a noninvasive stool DNA test to detect the presence of colon cancer. As of July, Cologuard had an approximately 6% market share in colon cancer screening.

The American Cancer Society updated its guidance for colorectal cancer screening in May 2018 to include patients ages 45 and older, from its previous guidance of 50 years and above.

However, the device is not a replacement for colonoscopy in high-risk individuals, including those with a history of colorectal cancer, the company said in a Sept. 23 press release.