Colorectal cancer screening solutions
We understand the challenges facing health systems
- No family history of CRC
- Lack of symptoms
- Procrastination
- Racial disparities
- Cost
- Fear and bowel prep concerns about colonoscopy
- Lack of doctor recommendations
References and footnotes
- 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 April 2, 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 April 2, 2024. https://nccrt.org/resource/2019messagingguidebook/
- Data on file. Exact Sciences Corporation. Madison, WI.
- 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. 2018;68(4):250-281.
- 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
- Colorectal cancer screening (COL, COL-E). National Committee for Quality Assurance. Accessed April 10, 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 June 3, 2024. a href="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" target="_blank">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 April 18, 2024. https://www.ncqa.org/wp-content/uploads/2022/03/MY-2022-Vol-2-Technical-Update.pdf
- 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.7 The ACS recommended screening interval for mt-sDNA is every 3 years.8 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-party 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).12
ACS=American Cancer Society; DNA=deoxyribonucleic acid; FIT=fecal immunochemical test; mt-sDNA=multitarget stool DNA; NCQA=National Committee for Quality Assurance; USPSTF=United States Preventive Services Task Force.
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