FDA recommends Cologuard stool-based DNA test for colon cancer after it demonstrates 93.3 pct sensitivty

By Rhodi Lee, Tech Times | March 28, 7:52 AM

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Colon Cancer

The number of adults getting screened for colon cancer 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.
(Photo : Wikimedia Commons)

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.  

Findings of a study published in the New England Journal of Medicine last week suggest that Cologuard is more efficient in detecting early-stage cancer than the Fecal Immunochemical Test (FIT), another non-invasive colon cancer screening test. The study, which was participated by 12,776 individuals, found that Exact Science's stool-based DNA test could detect 92.3 percent of colon cancers. Cologuard was also found to be 94 percent efficient in detecting early stage cancers.

Colonoscopy remains to be the most accurate way of detecting colon cancer but many avoid it because of its invasive approach of inserting a tube into the patient's anus. Cologuard will be used as a screening test if it gets FDA's approval but patients found positive of cancer will still be asked to undergo colonoscopy.

Symptoms of colon cancer do not often show up until the disease is already in its later stage. Health experts recommend screening so the disease can be detected in its early stage when it still has better chances of getting cured. The disease is one of the leading causes of cancer-related deaths in the United States.

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