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-group analysis of near-age groups.

Cologuard test box

Importance of Screening On-Time

Colorectal cancer (CRC) is the most preventable yet least prevented form of cancer2

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Cologuard Clinical Evidence

Cologuard is clinically shown to detect or rule out colorectal cancer

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Ordering Cologuard

Cologuard can be ordered through the provider portal or customizable order form

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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.

ACS makes a qualified recommendation for screening in patients age 45-49 and a strong recommendation for screening in patients 50-75.3

*Internal data. Exact Sciences Laboratories. Cologuard’s compliance rate represents the cumulative completed tests from kits shipped to patients during the 6-month period ending 12 months prior to the end of the most recent quarter reported, excluding program orders.

1. 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. 2. Itzkowitz SH. Incremental advances in excremental cancer detection tests. J Natl Cancer Inst. 2009;101(18):1225-1227. 3. Wolf A, Fontham E, Church T, et al. Colorectal Cancer Screening for Average-Risk Adults: 2018 Guideline Update From the American Cancer Society. Ca Cancer J Clin. 2018;68:250–281.