Scalable CRC screening solutions

Physician reviewing CRC screening rates on a large lightboard with six monitors.
See how the Cologuard® test can help close the colorectal cancer (CRC) screening gap
Prioritize the patients who need colonoscopy most

It’s estimated it would take ~10 years to screen every eligible patient for CRC with colonoscopy alone.1-3*     Stool-based CRC screening tests have the potential to reduce the colonoscopy backlog by prioritizing higher-risk patients for the procedure.4

Offering the Cologuard test to average-risk patients aged 45+ years can help health systems prioritize colonoscopies for patients who need them most.5

Our team can help your health system estimate its backlog of colonoscopies and identify options to help address it.

Elevate CRC screening rates at scale to help meet and exceed the national 80% CRC screening goal6,7
The Cologuard test supports multiple evidence-based pathways for CRC screening. Digital patient touchpoints ensure follow-through every step of the way.
Help achieve screening quality measure goals

The Cologuard test satisfies 3 years of Healthcare Effectiveness Data and Information Set (HEDIS®)† quality measures for CRC screening vs 1 year for FIT.8,9‡

  • Years to screen each eligible patient calculated based on ~60 million patients at average risk due for CRC screening, ~14,000 actively practicing gastroenterologists in the United States, and the estimated 426 colonoscopies performed by each gastroenterologist annually.1-3
Sanitas Medical Center logo

Learn how collaborating with Exact Sciences helped Sanitas Medical Center achieve 111% higher CRC screening rates over 4 years.10§

The current CRC screening landscape

The USPSTF currently recommends stool-based and direct visualization screening tests to detect cancer and pre-cancer. Blood tests are not yet included in guideline recommendations or commercial payer coverage.11‖
Chart showing current CRC landscape.

    ‖        Not included as of August 2024.11

    ¶        Indicated for the detection of fecal occult blood.12

    #        Current FDA-approved CRC blood test does not detect 87% of precancerous lesions.15

The Cologuard test is included in CRC screening guidelines11,19

US Preventive Services Task Force (USPSTF)
Several recommended screening tests are available. Clinicians and patients may consider a variety of factors in deciding which test may be best for each person.
American Cancer Society (ACS)
The importance of offering a choice between structural or stool-based testing is included in this guideline in recognition of the role of patient values and preferences and as a practical implementation strategy to improve adherence.
The Cologuard test offers easy ordering and broad, nationwide coverage

More than 96% of Cologuard patients nationwide have no out-of-pocket costs for screening10**    

The Cologuard and Cologuard Plus tests are strong clinical complements to colonoscopy that can help health systems screen patients for CRC. We make ordering simple by verifying which test is covered by a patient’s insurance before an order is processed.
Couple sitting at a kitchen table reviewing information on a laptop.

Connect with us

Explore how we can support your health system's goals for improving CRC screening rates.
Learn how incorporating the Cologuard test may increase your system's screening rates
Health system experiences with the Cologuard test
Discover how your Electronic Health Record (EHR) can enable optimized workflows

Footnotes and references

  1. Years to screen each eligible patient calculated based on ~60 million patients at average risk due for CRC screening, ~14,000 actively practicing gastroenterologists in the United States, and the estimated 426 colonoscopies performed by each gastroenterologist annually.1-3
  2. HEDIS® is a registered trademark of the National Committee for Quality Assurance (NCQA).
  3. OC FIT-CHEK, Polymedco, Inc.
  4. Based on a June 2023 internal report on a colorectal cancer screening quality improvement program conducted at Sanitas Medical Center.10
  5. Not included as of August 2024.11
  6. Indicated for the detection of fecal occult blood.12
  7. Current FDA-approved CRC blood test does not detect 87% of precancerous lesions.15
  8. Exact Sciences’ estimate based on historical patient billing as of November 2024. Exceptions for coverage may apply; only patients’ insurers can confirm how the Cologuard test would be covered.10

FDA=US Food and Drug Administration;  FIT=fecal immunochemical test;  mt-sDNA=multitarget stool DNA


  1. Ebner DW, Kisiel JB, Fendrick AM, et al. Estimated average-risk colorectal cancer screening-eligible population in the US. JAMA Netw Open. 2024;7(3):e245537.
  2. Active physicians with a U.S. doctor of medicine (U.S. MD) degree by specialty, 2015. AAMC. Updated December 2015. Accessed December 3, 2024. https://www.aamc.org/data-reports/workforce/interactive-data/active-physicians-us-doctor-medicine-us-md-degree-specialty-2015
  3. Eberth JM, Josey MJ, Mobley LR, et al. Who performs colonoscopy? Workforce trends over space and time. J Rural Health. 2018;34(2):138-147. 
  4. Fendrick AM, Ebner D, Kisiel JB, et al. Eliminating the colonoscopy backlog with stool-based colorectal cancer screening options. Gastroenterology. 2024;166(5):s358-s359.
  5. Cologuard® Clinician Brochure. Madison, WI: Exact Sciences Corporation.
  6. 80% in every community. National Colorectal Cancer Roundtable. Accessed December 3, 2024. https://nccrt.org/our-impact/80-in-every-community
  7. Prince M, Lester L, Chiniwala R, Berger B. Multitarget stool DNA tests increases colorectal cancer screening among previously nonadherent Medicare patients. World J Gastroenterol. 2017;23(3):464-471.
  8. NCQA updates HEDIS measure for colorectal cancer screening. Healio. October 6, 2016. Accessed December 3, 2024. https://www.healio.com/news/gastroenterology/20161006/ncqa-updates-hedis-measure-for-colorectal-cancer-screening
  9. Colorectal cancer screening (COL, COL-E). National Committee for Quality Assurance. Accessed December 3, 2024. https://www.ncqa.org/hedis/measures/colorectal-cancer-screening/
  10. Data on file for Sanitas case study. Health System Marketing. 2023. Exact Sciences Corporation. Madison, WI.
  11. 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.
  12. Screening tests to detect colorectal cancer and polyps. National Cancer Institute. Updated August 2, 2021. Accessed December 3, 2024. https://www.cancer.gov/types/colorectal/screening-fact-sheet
  13. Colorectal cancer early detection, diagnosis, and staging. American Cancer Society. Accessed December 3, 2024. https://www.cancer.org/content/dam/CRC/PDF/Public/8606.00.pdf
  14. FDA 510(k) substantial equivalence determination decision summary: K092330. US Food and Drug Administration. Accessed December 3, 2024. https://www.accessdata.fda.gov/cdrh_docs/reviews/K092330.pdf
  15. Shield Provider Brochure. Guardant Health. Accessed December 3, 2024. https://shieldcancerscreen.com/wp-content/uploads/LBL-000351-R1-Shield-Provider-Labeling.pdf
  16. Proposed changes to existing measure for HEDIS® MY 2022: colorectal cancer screening (COL). National Committee for Quality Assurance. Accessed December 3, 2024. https://www.ncqa.org/wp-content/uploads/2021/09/01.-COL.pdf
  17. UnitedHealthcare® Quality Reference Guide: 2024 HEDIS®, CMS Part D, CAHPS® and HOS Measures. UnitedHealthcare®. Accessed December 3, 2024. https://www.uhcprovider.com/content/dam/provider/docs/public/reports/path/2024-PATH-Reference-Guide.pdf
  18. Healthcare Effectiveness Data and Information Set (HEDIS®) Measurement Year 2024 Volume 2: summary table of measures, product lines and changes. National Committee for Quality Assurance. Accessed December 3, 2024. https://www.ncqa.org/wp-content/uploads/Summary-Table-of-Measures-Product-Lines-and-Changes.pdf
  19. Wolf AMD, Fontham ETH, Church TR, et al. Colorectal cancer screening for average-risk adults: 2018 guideline update from the American Cancer Society. CA Cancer J Clin. 2018;68(4):250-281.

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.