Additional Evidence

  • Clinical Utilization

    Real-world data suggest growing patient and provider interest in the mt-sDNA test as a non-invasive screening modality for average-risk colorectal cancer (CRC) screening.1 Furthermore, real-world data have demonstrated the clinical effectiveness of mt-sDNA in diverse clinical practice.2

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  • Discordant Results

    Follow-up colonoscopy findings may be negative for colorectal cancer (CRC) after a positive multi-target stool DNA (mt-sDNA) screening result. However, the incidence of aerodigestive cancers were uncommon among average-risk individuals with negative colonoscopy results, regardless of concordance with mt-sDNA results.4

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  • Adherence

    Real-world studies have indicated that adherence with mt-sDNA testing is high,5,6 even among previously non-adherenta patients.6  Studies also suggest that adherence with a follow-up colonoscopy is high after a positive mt-sDNA result.7,8

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Learn more about the full Indications/Contraindications for the mt-sDNA test.   Please see complete prescribing information for Cologuard in the Cologuard Clinician Brochure

References

1 Limburg PJ, Finney Rutten LJ, Ozbay AB, et al. Recent trends in colorectal cancer screening methods based on Medicare claims data. Curr Med Res Opin. 2021;37(4):605-607.

2 Anderson JC, Robinson CM, Hisey WM, et al. Colorectal Neoplasia detection in individuals with positive multitarget stool DNA tests: Data from the New Hampshire Colonoscopy registry. J Clin Gastroenterol. 2021. Epub ahead of print.

3 Ladabaum U, Mannalithara A. Comparative effectiveness and cost effectiveness of a multi-target stool DNA test to screen for colorectal neoplasia. Gastroenterol. 2016;151(3):427-439.e6.

4 Berger BM, Kisiel JB, Imperiale TF, et al. Low incidence of aerodigestive cancers in patients with negative results from colonoscopies, regardless of findings from multitarget stool DNA tests. Clin Gastroenterol Hepatol. 2020; 18(4): 864-871.

5 Weiser E, Parks PD, Swartz RK, et al. Cross-sectional adherence with the multi-target stool DNA test for colorectal cancer screening: real-world data from a large cohort of older adults. J Med Screen. 2021;28(1):18-24.

6 Prince M, Lester L, Chiniwala R, Berger B. Multitarget stool DNA tests increases colorectal cancer screening among previously noncompliant  Medicare patients. World J Gastroenterol.  2017;23(3):464-471.

7 Eckmann JD, Ebner DW, Bering J, et al. Multitarget stool DNA screening in clinical practice: high positive predictive value for colorectal neoplasia regardless of exposure to previous colonoscopy. Am J Gastroenterol. 2020;115(4):608-615.

8 Rutten LJF, Jacobson DJ, Jenkins GD, et al. Colorectal cancer screening completion: an examination of differences by screening modality. Prev Med Rep. 2020 Sep 11;20:101202.

 

Footnotes

a Nonadherence with CRC screening recommendations was defined as >10 years since last colonoscopy and/or >1 year since last FOBT.

 

Last Updated: 04/22/2023