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

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

Elevate CRC screening rates at scale to help meet and exceed the national 80% CRC screening goal5,6
The Cologuard test supports multiple evidence-based pathways. 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®) CRC screening quality measure credit vs 1 year for FIT.7,8†
  • 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.9

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. 10‡
Chart showing current CRC landscape.
    ‡          Not included as of August 2024
    §          Indicated for the detection of fecal occult blood
    ||          Current FDA-approved CRC blood test does not detect 87% of pre-cancerous lesions
    ¶          HEDIS® is a registered trademark of the National Committee for Quality Assurance (NCQA)

The Cologuard test is included in CRC screening guidelines10,18

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 has broad nationwide coverage

More than 96% of Cologuard patients nationwide have no out-of-pocket costs for screening19#

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

References and footnotes

  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 April 10, 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. Sa1144 Eliminating the colonoscopy backlog with stool-based colorectal cancer screening options. Gastroenterology. 2024;166(5):S358-S359.
  5. 80% in every community. National Colorectal Cancer Roundtable. Accessed April 10, 2024. https://nccrt.org/our-impact/80-in-every-community
  6. 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.
  7. NCQA updates HEDIS measure for colorectal cancer screening. Healio. October 6, 2016. Accessed April 10, 2024. https://www.healio.com/news/gastroenterology/20161006/ncqa-updates-hedis-measure-for-colorectal-cancer-screening
  8. Colorectal cancer screening (COL, COL-E). National Committee for Quality Assurance. Accessed April 10, 2024. https://www.ncqa.org/hedis/measures/colorectal-cancer-screening/
  9. Data on file. July 2024. Sanitas Case Study. Exact Sciences Corporation. Madison, WI.
  10. 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.
  11. Screening tests to detect colorectal cancer and polyps. National Cancer Institute. Updated August 2, 2021. Accessed August 6, 2024. https://www.cancer.gov/types/colorectal/screening-fact-sheet
  12. Colorectal cancer early detection, diagnosis, and staging. American Cancer Society. Accessed August 6, 2024. https://www.cancer.org/content/dam/CRC/PDF/Public/8606.00.pdf
  13. FDA 510(k) substantial equivalence determination decision summary. US Food and Drug Administration. Accessed November 19, 2024. https://www.accessdata.fda.gov/cdrh_docs/reviews/K092330.pdf
  14. Guardant Health. Shield Provider Brochure. Palo Alto, CA.
  15. Proposed changes to existing measure for HEDIS® MY 2022: colorectal cancer screening (COL). National Committee for Quality Assurance. Accessed August 6, 2024. https://www.ncqa.org/wp-content/uploads/2021/09/01.-COL.pdf
  16. UnitedHealthcare® Quality Reference Guide: 2024 HEDIS®, CMS Part D, CAHPS® and HOS Measures. UnitedHealthcare®. Accessed August 6, 2024. https://www.uhcprovider.com/content/dam/provider/docs/public/reports/path/2024-PATH-Reference-Guide.pdf
  17. 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 August 6, 2024. https://www.ncqa.org/wp-content/uploads/Summary-Table-of-Measures-Product-Lines-and-Changes.pdf
  18. 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.
  19. Data on file. November 2023. Exact Sciences Corporation. Madison, WI.


† OC FIT-CHEK, Polymedco, Inc.

# Exact Sciences estimate based on historical patient billing rate. Rate of coverage varies by state and region. Exceptions for coverage may apply; only patients’ insurers can confirm how the Cologuard test would be covered.19

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

Indications and Important Risk Information

The Cologuard® test 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 colonoscopy. The Cologuard test is indicated to screen adults of either sex, 45 years or older, who are at typical average risk for CRC. The Cologuard test is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.

The Cologuard test 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 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 colorectal cancer or advanced adenomas 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 test performance in patients ages 45 to 49 years was estimated by sub-group analysis of near-age groups.

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