The FDA approved the Cologuard home testing kit for those at risk of colorectal cancer. It’s hoped it will allow earlier detection and treatment response to this aggressive type of cancer.
Statistics show that colon cancer is currently “the third most commonly diagnosed cancer and the second leading cause of cancer death in men and women combined in the US. The American Cancer Society estimates 136,830 people will be diagnosed in 2014 and 50,310 will die from colon cancer in the United States.” The approval of this in-home device will hopefully reduce those figures.
Cologuard will cost $599 and is up to 90% effective in diagnosing the presence of colorectal cancer markers in the stool. Patients will be able to order the kit through their doctors and test themselves at home with a minimum of fuss. It will not require dietary restrictions, or any medication in preparation. Patients will then send the sample back to the lab in the pre-paid mailer bag.
Exact Sciences is the patent owner, and they’ve set up an automated testing process which will determine whether you have any precancerous polyps or cancer present in the stool. You’ll get the results back in approximately two weeks from your physician. If the test is positive, you’ll be advised to undergo a diagnostic colonoscopy for further diagnostic purposes.
In a statement, David Ahlquist MD, the co-inventor of the test said, “The test is designed for high accuracy, ease of patient use, and wide accessibility. We hope that it will make a difference and save many lives.”
The FDA also made it clear that their approval of this test doesn’t change the recommended guidelines for managing the risk of colon cancer. If you are between 50 and 75 and have genetic or prior markers for colon cancer, you may want to go one step further and undertake blood testing, sigmoidoscopy or colonoscopy as a precaution.
Many will be saying that $600 is a little out of their budget, but The Clinical Advisor reports that, “CMS proposes to cover the Cologuard test once every three years for Medicare beneficiaries who meet all of the following criteria: are aged 50 to 85 years and have no signs or symptoms of colorectal disease [including but not limited to] lower gastrointestinal pain, blood in stool, positive guaiac fecal occult blood test or fecal immunochemical test.”
To receive the Medicare cover you’ll also need to have, “No personal history of adenomatous polyps, of colorectal cancer, or inflammatory bowel disease, including Crohn Disease and ulcerative colitis; no family history of colorectal cancers or an adenomatous polyp, familial adenomatous polyposis, or hereditary nonpolyposis colorectal cancer.
It can sound complex, but despite this new Cologuard test, and the wealth of other information online, the best person to ask about your health may still be your doctor. They’ll have access to this test when it hits the market and can provide you with personal advice to make sure you’re taking the right steps to protect your health.