What are the risks and precautions associated with Cologuard?
Cologuard is not for everyone. It is not a replacement for diagnostic or surveillance colonoscopy in high-risk individuals. It may not be right for you if:
- You have a 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
- Results should be interpreted with caution for individuals over age 75, as the rate of false positives increases with age
Cologuard may produce false positive or false negative results.
- A false positive occurs when Cologuard produces a positive result, even though a colonoscopy will not find cancer or precancer. Any positive result should be followed by diagnostic colonoscopy.
- A false negative occurs when Cologuard does not detect colon cancer or precancer even when a colonoscopy identifies the positive result. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient.
Cologuard performance when used for repeat testing has not been evaluated or established.