FDA approves colonoscopy alternative developed at Mayo Clinic


The U.S. Food and Drug Administration approved a new, noninvasive test that screens for colon cancer.

KARE reports the screening test, called Cologuard, was developed by the Mayo Clinic and Exact Sciences. The take-home, stool DNA test could be given to patients instead of a colonoscopy and could revolutionize the screening process for colon cancer.

It is the first such test to have sensitivity rates comparable to a colonoscopy, according to a study published earlier this year in the New England Journal of Medicine. The study found that the test is reliable in identifying potentially fatal colon cancers without requiring the prep work or an invasive procedure. The Mayo Clinic study found that the test was 92 percent accurate at identifying patients with colon cancer, and 69 percent accurate at identifying patients with the bowel lesions or polyps that indicate a high risk for cancer.

The Star Tribune previously reported the new test requires people to send stool samples in the mail for laboratory analysis. The sample would be checked for the presence of red blood cells and DNA mutations.

The screening test could become an option for patients who are squeamish about the exam or concerned about its cost, said Dr. David Ahlquist, a Mayo gastroenterologist and co-inventor of the Cologuard system.

Cologuard is available to patients through their healthcare providers in the U.S. for $599.

A press release from Exact Science published on the Wall Street Journal site said the Mayo Clinic has licensed the technology to Madison-based Exact Sciences, which has plans to make Cologuard available in select countries in Europe. Under a licensing agreement, Mayo Clinic and Dr. Ahlquist share in equity and royalties. Revenue Mayo Clinic receives is used to support Mayo's not-for-profit mission in patient care, education and research.

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