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Copyright ©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Oncol. May 15, 2016; 8(5): 450-458
Published online May 15, 2016. doi: 10.4251/wjgo.v8.i5.450
Multitarget stool DNA for colorectal cancer screening: A review and commentary on the United States Preventive Services Draft Guidelines
Barry M Berger, Bernard Levin, Robert J Hilsden
Barry M Berger, Medical Affairs, Exact Sciences Corporation, Madison, WI 53719, United States
Bernard Levin, Scientific Advisory Board, Exact Sciences, New York, NY 10025, United States
Robert J Hilsden, Departments of Medicine and Community Health Sciences, University of Calgary, Calgary AB T2N 4N1, Canada
Author contributions: Berger BM contributed to the writing and data analysis and coordinated the writing of the paper; Levin B and Hilsden RJ contributed to the writing and data analysis.
Conflict-of-interest statement: Berger BM is an employee of Exact Sciences Corporation and owns stock interest in Exact Sciences Corporation; Levin B and Hilsden RJ are members of Exact Science’s Scientific Advisory Board and have received honoraria for meetings. No honoraria were provided for this review article.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Barry M Berger, MD, Chief Medical Officer, Medical Affairs, Exact Sciences Corporation, 5801 Research Park Blvd, Madison, WI 53719, United States. bberger@exactsciences.com
Telephone: +1-608-5358553
Received: December 23, 2015
Peer-review started: December 24, 2015
First decision: January 18, 2016
Revised: January 27, 2016
Accepted: March 14, 2016
Article in press: March 16, 2016
Published online: May 15, 2016
Processing time: 139 Days and 3.4 Hours
Core Tip

Core tip: Multi-target stool DNA (mt-sDNA) testing was approved for average risk colorectal cancer (CRC) screening by the United States Food and Drug Administration (2014). The evidence supporting mt-sDNA for routine screening use is robust. The clinical efficacy of mt-sDNA every three years, measured by life-years gained, and CRC deaths averted, is similar to that of other screening strategies more specifically recommended by the United States Preventive Services Task Force. In an irregularly screened population, however, tests with the highest point sensitivity and reasonable specificity like mt-sDNA are more likely to reduce CRC related morbidity and mortality than less sensitive tests that depend on annual adherence to achieve high programmatic sensitivity.