Changing the landscape of CRC screening. Together.

Take a Cologuard®-first approach to CRC screening

A Cologuard-first approach to colorectal cancer (CRC) screening, for average-risk patients aged 45+ years, can help close the screening gap and improve patient outcomes.1-5
James Schultz, MD quote: Using the Cologuard test [first] may be the best chance we have to meet the national goal to screen 80% of all eligible patients.

Screen more patients with a Cologuard-first approach

Using a risk-stratified approach that includes the Cologuard test first can help your health system screen more average-risk patients aged 45+ years and prioritize colonoscopies for higher-risk patients who need them most.1-3

  • The Cologuard test is proven to contribute to CRC screening adherence. About 71% of patients adhered to screening when offered a Cologuard test.4∗
  • Patients are also more likely to adhere to a follow-up colonoscopy following a positive Cologuard result than after a positive FIT result.5
Leigh Anne, CRC survivor quote: I'm living proof of the importance of early screening because I was offered Cologuard my CRC was caught early, and I got the care I needed.

High performance for CRC detection

With high adherence and high performance, the Cologuard test is a reliable screening modality for detecting CRC and precancer.2,4

When your patients receive the Cologuard test, your providers can rely on a screening test that delivers high sensitivity and high specificity for effectively detecting CRC and precancer early, when treatment is most effective.1,2,7

The Cologuard Plus™ test delivers:

  • High sensitivity for detection your clinicians can trust – with 95% CRC sensitivity, which is comparable to that of colonoscopy (also 95% according to USPSTF review)1,8
  • High specificity for fewer unnecessary colonoscopies† – 94% of adults without precancerous polyps or CRC tested negative when age weighted to the US population1‡
  • Reliability for greater confidence in negative results – with a 99.98% negative predictive value, meaning there is 99.98% certainty that a negative result accurately indicates a patient does not have CRC1§
Cologuard First. Cologuard as needed. For average-risk patients 45 and up.

More efficiency. Less administrative burden.

A Cologuard-first approach can be scaled to fit your system's needs.

  • Using the infrastructure you already have in place, we can help you optimize your system's workflow through EHR and technology-enabled dynamics to deliver a streamlined care model across the CRC screening experience.
  • Our proprietary platform for simplified and seamless ordering, paired with dedicated support from an experienced digital health team, can optimize your system's CRC screening processes.

Together, we can help more patients get screened to identify and prevent CRC.

Footnotes and references

  1. Results are from a retrospective analysis of aggregated laboratory data from Exact Sciences Laboratories LLC. 1,557,915 patients were identified as having received the Cologuard test kit via a point-of-care order for the first time between January 1, 2023, and June 1, 2023.4
  2. A positive Cologuard Plus result should always be followed up with a colonoscopy.1
  3. Cologuard Plus specificity: 91% overall specificity, including all participants who did not have advanced neoplasia. Specificity for no colorectal neoplasia was age-weighted to the US population and defined as a negative colonoscopy, no adenocarcinoma of the colorectum, no adenomas, and no sessile serrated polyps/sessile serrated adenomas.1
  4. The BLUE-C study evaluated the safety and efficacy of the Cologuard Plus test as a screening test for the detection of markers associated with the presence of colorectal cancer and advanced precancerous lesions in a prospective, cross-sectional, multicenter, pivotal trial. The primary performance measures were to determine the sensitivity of the Cologuard Plus test for colorectal cancer detection and to determine the specificity of the Cologuard Plus test for categories 3-6 (no advanced precancerous lesions or colorectal cancer). Secondary performance measures were to determine the sensitivity of the Cologuard Plus test for the detection of advanced precancerous lesions, compare sensitivities to the fecal immunochemical test, and evaluate the specificity of the Cologuard Plus test for participants with no colorectal neoplastic findings (category 6).1

CRC=colorectal cancer; EHR=electronic health record; FIT=fecal immunochemical test; USPSTF=United States Preventive Services Task Force.

  1. Cologuard Plus™ Clinician Brochure. Madison, WI: Exact Sciences Corporation.
  2. Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(14):1287-1297.
  3. Fendrick AM, Ebner DW, Kisiel JB, et al. Eliminating the colonoscopy backlog with stool-based colorectal cancer screening options. Abstract presented at: Digestive Disease Week (DDW) 2024 Annual Meeting; May 18-21, 2024; Washington, DC.
  4. Le QA, Greene M, Gohil S, et al. Adherence to multi-target stool DNA testing for colorectal cancer screening in the United States. Int J Colorectal Dis. 2025;40(1):16.
  5. Austin G, Kowalkowski H, Guo Y, et al. Patterns of initial colorectal cancer screenings after turning 50 years old and follow-up rates of colonoscopy after positive stool-based testing among the average-risk population. Current Med Res Opin. 2023;39(1):47-61.
  6. 80% in every community. National Colorectal Cancer Roundtable. Accessed April 15, 2025. https://nccrt.org/our-impact/80-in-every-community/
  7. Siegel RL, Kratzer TB, Giaquinto AN, Sung H, Jemal A. Cancer statistics, 2025. CA Cancer J Clin. 2025;75(1):10-45.
  8. Davidson KW, Barry MJ, Mangione CM, et al. Screening for colorectal cancer: US Preventive Services Task Force recommendation statement. JAMA. 2021;325(19):1965-1977.

Important Information about the Cologuard products


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.

Rx only.