Colorectal cancer screening solutions

We understand the challenges facing health systems

- No family history of CRC
- Lack of symptoms
- Procrastination
- Racial disparities
- Cost
- Transportation issues
- Required time away from work
- Fear and bowel prep concerns about colonoscopy
- Lack of doctor recommendations




Footnotes and references
- Up to date denotes testing with any recommended test within the appropriate time interval (10 years, 5 years, 3 years, or annually).3
- The USPSTF-recommended screening frequency for sDNA-FIT is every 1 to 3 years.9 The ACS recommended screening interval for mt-sDNA is every 3 years.10 Guidelines may refer to the Cologuard test by different names, including mt-sDNA, FIT-fecal DNA, sDNA, and sDNA-FIT.
- sDNA (ie, Cologuard test) is one of the methods permitted for patients at average risk aged 45 to 75 years as part of the National Committee for Quality Assurance’s (NCQA) HEDIS® quality measures for colon cancer screening. Third parties creating guidelines and quality measures do not specifically endorse commercial products, and inclusion in same does not imply otherwise. HEDIS® is a registered trademark of the National Committee for Quality Assurance (NCQA).14
ACS=American Cancer Society; FIT=fecal immunochemical test; mt-sDNA=multitarget stool DNA; NCQA=National Committee for Quality Assurance; USPSTF=United States Preventive Services Task Force.
- 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.
- Itzkowitz SH. Incremental advances in excremental cancer detection tests. J Natl Cancer Inst. 2009;101(18):1225-1227.
- American Cancer Society. Colorectal Cancer Facts & Figures 2023-2025. Atlanta: American Cancer Society; 2023.
- 80% in every community. National Colorectal Cancer Roundtable. Accessed December 3, 2024. https://nccrt.org/80-in-every-community/
- 2019 colorectal cancer screening messaging guidebook: recommended messages to reach the unscreened. National Colorectal Cancer Roundtable. Accessed December 3, 2024. https://nccrt.org/resource/2019messagingguidebook/
- Jones RM, Devers KJ, Kuzel AJ, Woolf SH. Patient-reported barriers to colorectal cancer screening: a mixed-methods analysis. Am J Prev Med. 2010;38(5):508-516.
- Cologuard® Clinician Brochure. Madison, WI: Exact Sciences Corporation.
- Cologuard Plus™ Clinician Brochure. Madison, WI: Exact Sciences Corporation.
- 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.
- 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. 2108;68(4):250-281.
- 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
- Colorectal cancer screening (COL, COL-E). National Committee for Quality Assurance. Accessed December 3, 2024. https://www.ncqa.org/hedis/measures/colorectal-cancer-screening/
- FDA approves Exact Sciences’ Cologuard®; first and only stool DNA noninvasive colorectal cancer screening test. News release. Exact Sciences Corporation. August 12, 2014. Accessed December 3, 2024. https://investor.exactsciences.com/investor-relations/press-releases/press-release-details/2014/FDA-Approves-Exact-Sciences-Cologuard-First-and-Only-Stool-DNA-Noninvasive-Colorectal-Cancer-Screening-Test/default.aspx
- Healthcare Effectiveness Data and Information Set (HEDIS®) Measurement Year 2022 Volume 2: Technical Update. National Committee for Quality Assurance. March 31, 2022. Accessed December 3, 2024. https://www.ncqa.org/wp-content/uploads/2022/03/MY-2022-Vol-2-Technical-Update.pdf
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.