Important Risk Information

Indications for Use

The Cologuard® and Cologuard Plus™ tests are intended for the qualitative detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. A positive result may indicate the presence of colorectal cancer (CRC) or advanced adenoma (AA)/advanced precancerous lesions (APL) and should be followed by a colonoscopy. The Cologuard test and Cologuard Plus test are indicated to screen adults of either sex, 45 years or older, who are at average risk for CRC. These tests are not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.

Cologuard should not be used if you:

  • have a history of colorectal cancer, adenomas or other related cancers
  • had a positive result from another colorectal cancer screening test within the last 6 months
  • have a condition that places you at high risk for colorectal cancer, including Inflammatory Bowel Disease (IBD) or certain hereditary syndromes or a family history of colorectal cancer

Talk to your healthcare provider if any of these situations apply to you.


Cologuard results should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for colonoscopy.


A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their healthcare provider when they need to be tested again.


False positives and false negatives can occur. It is important to talk to your doctor about your test results.


Do not provide a sample if you have diarrhea or have blood in your urine or stool.


The risks related to using the Cologuard collection kit are low, with no serious adverse events reported among people in a clinical trial. You should be careful when opening and closing the lids to avoid the risk of hand strain.


Please read the Instructions for Use and talk to your healthcare provider to see if a Cologuard test is right for you. This product is available by prescription only.


Refer to the Cologuard Patient Brochure or the Cologuard Plus Patient Brochure for additional information on the about the benefits and risk of using each version of the Cologuard product for CRC screening.