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Cologuard


Cologuard is a stool based colon cancer screening test based on the detection of DNA in abnormal cancerous or pre-cancerous cells that may be shed in the stool.  It is indicated for adults 50 years or older who are at average risk for colon cancer.  In a study, Cologuard found 92% of colon cancers and 69% of high-risk precancers . Therefore, it missed 8% of cancers and 31% of advanced pre-cancerous polyps.  Both false positives and false negatives do occur.  13% of people without cancer or precancer tested positive. Any positive should be followed by a diagnostic colonoscopy. 

Cologuard is not for everyone.  It is not a replacement for diagnostic or surveillance colonoscopy in higher risk individuals.  Those patients at increased risk include:

  • Personal history of colon cancer, polyps, or other related cancers
  • You have a family history of colon cancer
  • You have had a positive result for another screening method in the last six months
  • You have been diagnosed with a condition that places you at high risk for colon cancer. These include but are not limited to: Inflammatory Bowel Disease, Chronic ulcerative colitis, Crohn’s disease, Familial adenomatous polyposis
  • You have been diagnosed with a relevant cancer syndrome passed on from your family, such as Hereditary non-polyposis colorectal cancer syndrome, Peutz-Jeghers Syndrome, MYH-Associated Polyposis, Gardner’s syndrome, Turcot’s (or Crail’s) syndrome, Cowden’s syndrome, Juvenile Polyposis, Cronkhite-Canada syndrome, Neurofibromatosis, or Familial Hyperplastic Polyposis
The Cologuard Collection Kit is shipped directly to your home following an order from your provider. You collect a single stool sample using this kit then send it to Exact Sciences Labs. The results are then provided to the ordering provider. 

As of March 2017, the list price of Cologuard is $649. Insurance may cover some or all of that amount depending on the patient's insurance plan and benefits. Patients with traditional Medicare and Medicare Advantage plans do not have any co-pays or deductible amounts.  Medicare will not cover the test if you have symptoms that your doctor thinks may be related to colon cancer, if you previously had a positive colonoscopy that found polyps or cancer, or if your doctor determines that you have a high-risk family history of colon cancer.
 

Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(14):1987-97