FDA Approves DNA-based Colon Cancer Screening Test

Monday brought exciting news to the world of gastroenterology. The Food and Drug Administration approved its first screening test for colon cancer that uses patients’ DNA to identify potentially deadly tumors and growth. The approval of this test is even more exciting for us here at Utah Digestive Health Institute as our providers proudly participated in the clinical trials associated with what is being called the Cologuard test.

The Cologuard test is used to detect any irregular mutations existing in stool samples. These mutations can be an early indication and warning sign of cancer. When this special test yields a positive result, patients are encouraged to undergo a colonoscopy.Utah Digestive Health Institute

While physicians have used stool tests to identify signs of tumors and precancerous polyps, the Cologuard test’s accuracy is extremely impressive. Cologuard detected 92 percent of colon cancers and 42 percent of advanced polyps during clinical trials. Compared to traditional blood tests whose screening only detected 74 percent of cancers and 24 percent of advanced polyps, the Cologuard test brings new hope to colon cancer prevention efforts.

Despite the tests results and apparent superiority, FDA officials stress that DNA-based stool screening has not been endorsed by federal medical advisers who set screening guidelines. Coupled with the cost of the Cologuard test, which is estimated at $599 per patient, the best method for colon cancer detection and prevention is still a colonoscopy. It is estimated that the United States spends over $14 billion annually treating cases of colon cancer that go undetected. It is no wonder rigorous efforts to increase colon cancer awareness continue.

One thing is for certain, the strides medical researchers are making are encouraging. The Cologuard test is sure to be the first of many new cancer detection tests to come out and gain FDA approval in the coming years. And that has the medical community buzzing with excitement.