~44 million patients remain unscreened for colorectal cancer (CRC).1-7* Some of them may even be in your practice.
*Estimate based on the US population aged 45 to 74 years as of 2018, adjusted for the reported rates of high-risk conditions and prior screening history for CRC.
Indication and Important Risk Information Cologuard 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 diagnostic colonoscopy. Cologuard is indicated to screen adults of either sex, 45 years or older, who are at typical average risk for CRC. Cologuard is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.
Cologuard 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 diagnostic 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 performance in patients ages 45 to 49 years was estimated by sub-group analysis of near-age groups.
Cologuard performance when used for repeat testing has not been evaluated or established. Rx only.
References: 1. Annual estimates of the resident population for selected age groups by sex for the United States: April 1, 2010 to July 1, 2018. United States Census Bureau website. https://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=PEP_2018_PEPAGESEX&prodType=table. Updated June 2019. Accessed November 12, 2019. 2. SEER cancer statistics review 1975-2016. Howlader N, Noone AM, Krapcho M, et al, eds. National Cancer Institute website. https://seer.cancer.gov/csr/1975_2016/browse_csr.php?sectionSEL=6&pageSEL=sect_06_table.10. Updated September 5, 2019. Accessed November 12, 2019. 3. Henrikson NB, Webber EM, Goddard KA, et al. Family history and the natural history of colorectal cancer: systematic review. Genet Med. 2015;17(9):702-712. 4. Loftus EV Jr. Update on the incidence and prevalence of inflammatory bowel disease in the United States. Gastroenterol Hepatol (NY). 2016;12(11):704-707. 5. Colorectal Cancer Facts & Figures 2017-2019. American Cancer Society website. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/colorectal-cancer-facts-and-figures/colorectal-cancer-facts-and-figures-2017-2019.pdf. Accessed November 12, 2019. 6. Fedewa SA, Siegel RL, Jemal A. Are temporal trends in colonoscopy among young adults concordant with colorectal cancer incidence? J Med Screen. 2019;26(4):179-185. 7. Use of colorectal cancer screening tests: 2018 Behavioral Risk Factor Surveillance System. Centers for Disease Control and Prevention website. https://www.cdc.gov/cancer/colorectal/statistics/use-screening-tests-BRFSS.htm. Updated October 22, 2019. Accessed November 12, 2019. 8. Inadomi JM, Vijan S, Janz NK, et al. Adherence to colorectal cancer screening: a randomized clinical trial of competing strategies. Arch Intern Med. 2012;172(7):575-582. 9. 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.
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