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Cover of Fecal DNA Testing in Screening for Colorectal Cancer in Average-Risk Adults

Fecal DNA Testing in Screening for Colorectal Cancer in Average-Risk Adults

Comparative Effectiveness Reviews, No. 52

Investigators: , MD, MCR, , MS, , MS, , PhD, and , MD, MPH.

Author Information
Rockville (MD): Agency for Healthcare Research and Quality (US); .
Report No.: 12-EHC022-EF

Structured Abstract


To review the evidence on fecal DNA testing to screen for colorectal cancer in adults at average risk for colorectal cancer.

Data sources:

We searched MEDLINE, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects, and the Health Technology Assessments Database from 2000 through August 11, 2011 and grey literature including recent conference abstracts, regulatory documents, unpublished information from the manufacturer, and expert suggestions.

Review methods:

Two investigators independently reviewed all abstracts and full-text articles against a set of a priori inclusion criteria and assessed the quality of included articles using established criteria. Disagreements were resolved through consultation of a third investigator. We evaluated and summarized clinical and methodological characteristics and internal and external validity of studies. Finally, we assessed the overall strength of evidence for each outcome based on risk of bias, consistency, directness, and precision of the evidence.


Despite the availability of numerous excluded initial validation studies of fecal DNA testing, we found only three studies that examined the test accuracy of fecal DNA testing in screening populations. Initial validation studies were excluded due to their use of highly selected patient populations. Two fair-quality diagnostic accuracy studies (n=5004) evaluating a multi-marker fecal DNA found differing sensitivities to detect CRC (25 percent [95% CI, 5 to 57 percent] versus 51.6 percent, [95% CI, 34.8 to 68.0]). Sensitivity for advanced adenomas was similarly low in both studies. Another small study and a subset analysis of one of the larger studies were both poor quality and evaluated different tests. We found no studies that specifically evaluated the harms of fecal DNA testing. While three poor-quality analytic validity studies showed that technological advances can improve the analytic sensitivity of assays, it is unclear if these advances are applicable to the currently available test. Six fair-to poor-quality studies that evaluated acceptability found that fecal DNA testing is generally acceptable, although an important test attribute for acceptability appears to be the test's accuracy (which is yet unknown). No studies have evaluated the relative acceptability of fecal DNA tests to FIT tests.


Fecal DNA tests have insufficient evidence about its diagnostic accuracy to screen for colorectal cancer in asymptomatic, average-risk patients. There is also insufficient evidence for the harms, analytic validity, and acceptability of testing in comparison to other screening modalities. Existing evidence has little or no applicability to currently available fecal DNA testing.

Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1, Contract No. HHS-290-2007-10057-I. Prepared by: Oregon Evidence-based Practice Center, Portland, Oregon

Suggested citation:

Lin JS, Webber EM, Beil TL, Goddard KA, Whitlock EP. Fecal DNA Testing in Screening for Colorectal Cancer in Average-Risk Adults. Comparative Effectiveness Review No. 52. (Prepared by the Oregon Evidence-based Practice Center under Contract No. HHS-290-2007-10057-I.) AHRQ Publication No. 12-EHC022-EF. Rockville, MD: Agency for Healthcare Research and Quality. February 2012. Available at:

This report is based on research conducted by the Oregon Evidence-based Practice Center under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. HHS-290-2007-10057-I). The findings and conclusions in this document are those of the authors, who are responsible for its contents; and findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.

The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.

This report may be used, in whole or in part, as the basis for the development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.

None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.


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Bookshelf ID: NBK91369PMID: 22457883


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