FDA Recommends Cologuard Stool-Based DNA Test for Colon Cancer After It Demonstrates 93.3 Pct Sensitivity

FDA Recommends Cologuard Stool-Based DNA Test for Colon Cancer After It Demonstrates 93.3 Pct Sensitivity

[Tech Times]

colon-cancer

Colon cancer screening is crucial because it can prevent colon-related cancer deaths by as much as 60 percent if adults who are at least 50-years old get screened routinely. What stops many people from getting screened though is the discomfort associated with traditional screening methods.

The number of adults getting screened for colon cancer, however, may soon increase as the U.S Food and Drug Administration (FDA) is likely to give its approval to a less invasive stool-based DNA test for detecting colon cancer.

On Thursday, a panel of FDA advisers unanimously recommended the approval of Cologuard, a colon cancer screening test that analyzes DNA found in the stool. The FDA may not follow the panel’s recommendation but it usually does. Cologuard was developed by Madison-based Exact Sciences which specializes in colon cancer.

“Exact Sciences Corp. (Nasdaq: EXAS) today announced that the U.S. Food and Drug Administration’s (FDA) Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee determined by a unanimous vote of 10 to zero that Exact Sciences has demonstrated safety, effectiveness and a favorable risk benefit profile of Cologuard, the company’s stool-based DNA (sDNA), non-invasive colorectal cancer screening test,” Exact Sciences announced on its website.

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