FDA approves alternative to colonoscopy

GOLDEN VALLEY, Minn. - The U.S. Food and Drug Administration has approved Cologuard, the first stool-based colorectal screening test.

Instead of a colonoscopy, which often scares people due to the prep work and the invasive procedure, a stool sample would be checked for the presence of red blood cells and DNA mutations. Doctors look for the presence of certain kinds of abnormal growths that may be cancers such as colon cancer or precursors to cancer.

The new screening was developed by the Mayo Clinic and Exact Sciences. Its noninvasive and the first such test to have sensitivity rates comparable to a colonoscopy, according to a recent study published in the New England Journal of Medicine.

"We know that 40 percent of the country is not exposed to a screening test of any kind," said study co-author and Mayo Clinic gastroenterologist Dr. John Kisiel. "So we're very excited to be able to offer patients a new choice for colorectal cancer screening in the hopes that it will improve participation in a regular screening program."

Cologuard is a take-home, stool DNA test.

"Polyps and cancer, both lesions, continually shed cells that end up in the stool. The Cologuard test can recover polyp or cancer related DNA in those exfoliated cells," Mayo Clinic gastroenterologist and Cologuard co-inventor, Dr. David Ahlquist said.

Researchers said that Cologuard won't replace a colonoscopy. If precancer or cancer is detected, Kisiel said a patient would then undergo a diagnostic colonoscopy as well.


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