In recognition of Colorectal Cancer Awareness Month 2025, our latest edition of the Guidelines+ Monographs Series will delve into the test Cologuard, from Exact Sciences. Cologuard® is a stool DNA-based colorectal cancer screening test for average-risk individuals who are 45 or older. Cologuard uses a biomarker panel which analyzes a person’s stool sample for 10 DNA markers, as well as blood in the stool (hemoglobin). It was initially approved in 2014.
In the following sections, we will provide a comprehensive overview of Cologuard and analyze its positioning across various guidelines for its approved indications.
Note* - This Guidelines+ Monographs for Cologuard is current as of March 2025. Consult our clinical guidelines library and/or or medication information look up tool to ensure you are always accessing the most current information.
Without further delay, let’s jump in!
Test Overview:
- Brand name: Cologuard
- Manufacturer(s): Exact Sciences
- Initial FDA Approval: August 2014
Indications and FDA Approval Details
Indicated Condition | Approvals | Age | Date Approved |
|---|---|---|---|
Colorectal Cancer Screening | Original approval for Cologuard. 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 diagnostic colonoscopy. Cologuard is indicated to screen adults of either 50 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. | 50 years of age or older | August 11, 2014 |
| Colorectal Cancer Screening | Approval expanded the indicated age range for Cologuard Stool DNA-Based Colorectal Cancer Screening Test from 50 years or older to 45 years or older. | 45 years of age or older | September 20, 2019 |
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.
Contraindications
The Cologuard products are not for high-risk individuals, including patients who have the following:
- a personal history of colorectal cancer and adenomas
- a positive result from another colorectal cancer screening method within a test recommended timeframe
- have been diagnosed with a condition associated with high risk for colorectal cancer such as IBD, chronic ulcerative colitis, Crohn’s disease
- have a family history of colorectal cancer, or certain hereditary syndromes
Warnings and Precautions
All positive results should be referred to colonoscopy.
The Cologuard products may produce false positive and false negative results. A false positive result occurs when a result is positive, even though a colonoscopy will not find CRC or APL. A false negative result occurs when a result is negative, even when a colonoscopy identifies APL or CRC.
A negative result does not guarantee the absence of colorectal cancer or advanced adenoma. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Performance when used for repeat testing has not been established.
Refer to the Cologuard test Clinician Brochure or the Cologuard Plus test Clinician Brochure for additional information about the benefits and risks of using each version of the Cologuard product for CRC screening.
Now that we’ve covered the basic monograph information for Cologuard, let’s take a closer look at how it is currently recommended in various clinical practice guidelines.
Specific Inclusions of Cologuard in the Guidelines
Colorectal Cancer: Screening -- Adults aged 45 to 49 years
- US Preventive Services Task Force (USPSTF)
- Publication: May 18, 2021
- The USPSTF found adequate evidence that screening eligible patients aged 45 to 49 years provides a moderate benefit in reducing CRC deaths and increasing life-years gained. USPSTF-recommended screening modalities include stool-based tests or direct visualization tests.
Colorectal Cancer Screening 2021
- American College of Gastroenterology (ACG)
- Publication: February 28, 2021
- The ACG suggests considering the following screening tests for individuals unable or unwilling to undergo colonoscopy or FIT: flexible sigmoidoscopy, multitarget stool DNA test, CT colonography, or colon capsule. (Conditional recommendation; very low-quality evidence)
Colorectal Cancer Screening for Average‐Risk Adults
- American Cancer Society (ACS)
- Publication: May 01, 2018
- The ACS recommends that adults aged 45 years and older with an average risk of colorectal cancer undergo regular screening with either a high-sensitivity stool-based test or a structural (visual) examination, depending on patient preference and test availability.
This concludes our Guidelines+ Monographs for Cologuard. This list is current as of March 2025, and may be updated over time as new indications are approved and/or new guidelines published or updated. Sign up for alerts and stay informed on the latest published guidelines and articles.
Copyright © 2025 Guideline Central, All Rights Reserved.