Indications for Use
Cologuard® is 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) and should be followed by a colonoscopy. Cologuard is indicated to screen adults of either sex, 45 years or older, who are at typical average risk for CRC. Cologuard is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high risk individuals.
Important Risk Information
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.
The Cologuard test result 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. In a clinical study, 13% of people without cancer received a positive result (false positive) and 8% of people with cancer received a negative result (false negative). It is important to talk to your doctor about your test results.
Cologuard performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older.
Do not provide a sample for Cologuard 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 Cologuard is right for you. This product is available by prescription only.
Cologuard® colorectal cancer screening test is a registered trademark of Exact Sciences Corporation.
For complete information on Cologuard, please click here.