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Multi-Target Stool DNA Test: A New High Bar for Noninvasive Screening

Abstract

Stool DNA testing has evolved into what is now a highly accurate and well-validated test for the screen detection of colorectal neoplasia. An optimized and automated multi-target stool DNA test (MT-sDNA) has achieved the same high point-sensitivities as reported for colonoscopy and significantly higher sensitivity than by fecal immunochemical blood testing for detection of early-stage cancer and advanced precancer. Thus, MT-sDNA sets a new high criterion standard for the noninvasive screen detection of colorectal neoplasia. With clinical application, MT-sDNA has potential to meaningfully address current gaps in our approach to CRC screening through benefits of its high accuracy on screening effectiveness, user-friendly features on patient compliance, and easy mail-out distribution on test access. The US Food and Drug Administration and Center for Medicaid and Medicare Services have recently completed their parallel reviews of MT-sDNA, which has just become available for clinical use. This review summarizes the recent clinical validation data on MT-sDNA, addresses central clinical questions at this front end of implementation, and touches on innovative future applications of stool DNA testing.

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Conflict of interest

Mayo Clinic is a minor equity investor in and has licensed technology to Exact Sciences related to the content of this review (Madison, WI, USA). Dr. Ahlquist is an inventor of licensed technology, a scientific advisor to Exact Sciences, and receives funding from Exact Sciences for collaborative research. In keeping with institutional policy, he shares royalties that come to Mayo Clinic. Dr. Ahlquist is solely responsible for the content of this review, and Exact Sciences played no role in its direction or preparation.

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Ahlquist, D.A. Multi-Target Stool DNA Test: A New High Bar for Noninvasive Screening. Dig Dis Sci 60, 623–633 (2015). https://doi.org/10.1007/s10620-014-3451-5

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Keywords

  • Colorectal cancer
  • Colorectal polyps
  • Molecular detection
  • Fecal blood testing
  • FIT