High sensitivity.1
High compliance.* Colorectal cancer (CRC) screening that's built for both

Covered by Medicare and most major insurers

Cologuard test box

Now approved in adults 45+ years old to screen those at average risk for colorectal cancer

The clinical validation study was conducted in patients 50 years of age and older. ACS Guidelines recommend screening begin at age 45. Cologuard performance in patients 45 to 49 years was estimated by sub-broup analysis of near-age groups.

Cologuard test box

CRC Screening redefined

A sensitive screening strategy that improves patient compliance.

That’s Cologuard.

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Ordering Cologuard

A screening strategy that’s simple for healthcare providers to order and easy for patients to use.

That’s Cologuard.

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National guidelines

Included in USPSTF and ACS guidelines, and included in NCQA HEDIS® quality measures.‡1,2,3

That’s Cologuard.

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*92% sensitivity‡4 in detecting colorectal cancers, stages I-IV. 87% specificity overall§4, excluding colorectal cancer and advanced adenomas. 68% compliance with Cologuard.

†Stool DNA (i.e. Cologuard) is one of the methods permitted as part of NCQA’s HEDIS® quality measures for colon cancer screening. Third party guidelines and quality measures do not specifically “endorse” commercial products, and inclusion in same does not imply otherwise.

‡Cologuard sensitivity, per stage of cancer: I: 90% (n = 29); II: 100% (n = 21); III: 90% (n = 10); IV: 75% (n = 4).5

§Cologuard specificity: 87% overall specificity excluding colorectal cancer and advanced adenoma; and including all nonadvanced adenomas, non-neoplastic findings, and negative results on colonoscopy. 90% specificity in participants with no lesions biopsied on colonoscopy.5

‖Internal data. Exact Sciences Laboratories. Cologuard's compliance rate represents the cumulative completed tests from kits shipped to patients during the six-month period ending 12 months prior to the end of the most recent quarter reported, excluding program orders.

1. Bibbins-Domingo K, Grossman DC, Curry SJ, et al; for US Preventive Services Task Force. Screening for colorectal cancer: US Preventive Services Task Force recommendation statement. JAMA. 2016;315(23):2564-2575.
2. American Cancer Society. American Cancer Society guidelines for early detection of cancer. Revised May 30, 2018. Accessed August 14, 2018.
3. National Committee for Quality Assurance website. HEDIS 2017 Volume 2 Technical Update. Accessed August 14, 2018.
4 Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014 Apr 3;370(14):1287-1297.
5 American Cancer Society. Cancer Facts & Figures 2017. American Cancer Society website. Accessed August 14, 2018.

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 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.

Cologuard is not for high-risk individuals, including patients with a personal history of colorectal cancer and adenomas; have had a positive result from another colorectal cancer screening method within the last 6 months; have been diagnosed with a condition associated with high risk for colorectal cancer such as IBD, chronic ulcerative colitis, Crohn’s disease; or have a family history of colorectal cancer, or certain hereditary syndromes.

Positive Cologuard results should be referred to diagnostic colonoscopy. A negative Cologuard test result does not guarantee absence of 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.

False positives and false negatives do occur. In a clinical study, 13% of patients without cancer received a positive result (false positive) and 8% of patients with cancer received a negative result (false negative). The clinical validation study was conducted in patients 50 years of age and older. Cologuard performance in patients ages 45 to 49 years was estimated by sub-group analysis of near-age groups.

Cologuard performance when used for repeat testing has not been evaluated or established. Rx only.

Cologuard is a registered trademark of Exact Sciences Corporation.