Cologuard At-Home Colon Cancer TestColorectal cancer is a cancer that develops in the tissues of the colon and/or rectum and typically affects men and women over the age of 50. If caught in time, the Federal Drug Administration reports at least 60% of deaths from this disease could be avoided. The American Cancer Society recommends people with an average risk for colorectal cancer also have a flexible sigmoidoscopy every five years or a colonoscopy every ten years.

A Colonoscopy is a diagnostic procedure performed by a gastroenterologist that uses a long, flexible and lighted tube with a tiny camera attached to its end. By inserting this tube through the rectum and into the colon, the doctor can inspect the lining for polyps or other abnormalities. They will also collect samples of tissue and cells for for biopsy.

Colon Cancer TestThe U.S. Food and Drug Administration has recently approved an at-home colon cancer test, called Cologuard. It is the first stool-based screening test ordered through a doctor’s office, completed at home, and mailed in for laboratory analysis. The test detects certain DNA mutations and red blood cells that could be indications of colorectal cancer. Cologuard could be used to help determine who is at risk of developing colorectal cancer at its earliest stages when the cancer is still asymptomatic. Patients who test positive with Cologuard would be advised to undergo further tests, including a colonoscopy.

There are currently two other previously approved screening tests usually done in a doctor’s office. The fecal occult blood test (FOBT) and fecal immunochemical test (FIT) detect the presence of human blood, an indication of potential colon cancer.

In March 2014, the New England Journal Medicine completed a study of the use of Cologuard. Each patient was screened three ways: by means of a standard colonoscopy; a commercially available fecal test (FIT); and the new DNA test. Colonoscopy screenings unearthed colon cancer in 65 participants, while another 757 were found to have advanced precancerous lesions. The new test accurately detected 60 of those 65 cancers. The FIT test spotted only 48 cancers, with an accuracy rate of 74% compared to 92% for the new test.

Although the new Cologuard adds another method for detecting some cases of colorectal cancer, it has both pros and cons. Says Dr. Won Kyoo Cho, Chief of Gastroenterology/Hepatology at MedStar Washington Hospital Center in Washington, “When it comes to spotting more abnormalities the test is very good. The Cologuard picks up about 92.3% of abnormalities, compared to 74% with the FIT.” But, Cho warns, “The downside is the new test was not as good at finding ‘true negatives.’ ”

The FDA says Cologuard correctly identifies a negative result in 87% of patients and the fecal immunochemical test correctly identifies negative results about 95% of the time. “That means you may be picking up abnormalities, but it doesn’t necessarily mean those abnormalities are cancerous, so the false positives are higher. Many people who test positive on the test may be worried for no reason.” said Cho.

The approval of Cologuard does not mean current colorectal cancer screening guidelines have changed. A colonoscopy is still the “gold standard” in colorectal cancer detection. In addition, Cho notes, “Colorguard does not detect polyps that could be the beginning of colon cancer. When you go in with a colonoscopy, you can snip those polyps out immediately. Done. But if you miss those polyps and they grow in the colon, you could be facing serious surgery, or even the possible spread of the cancer.”

At this point, the main issue with Cologuard is cost. According to Cologuard’s manufacturer, one test costs as much $600. But the FDA noted on the same day of the test’s approval, the Centers for Medicare and Medicaid Services issued a proposed national coverage, meaning Medicare will pay for the test once every three years for beneficiaries who meet a certain criteria. The criteria for Medicare payment and other insurances is not clear however there will be information coming soon. At present Aetna insurance does not pay and considers the test “experimental”.

As soon as the payment issue is settled Family Medicine Associates will offer the in-home testing to our patients. As soon as the payment issue is settled Family Medicine Associates will offer the in-home testing to our patients. At present, Colorguard screening is not indicated for people at high risk of colonoscopy such as: family history, certain polyps and inflammatory bowel disease. Talk to your provider at Family Medicine Associates during your next visit.


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