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.