Indications for Use
Cologuard® is intended to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Cologuard is not a replacement for surveillance colonoscopy in high risk individuals for diagnostic colonoscopy.
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 diagnostic 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 negative 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 healthcare provider 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.