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Stool DNA for Colorectal Cancer Screening: From Concepts to Quality Care

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Colorectal Cancer Screening

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Abstract

Stool DNA testing is an emergent noninvasive colorectal cancer (CRC) screening approach with attractive biological and clinical features. A specific next-generation multi-target stool DNA test (Cologuard; Exact Sciences, Madison, WI) was recently shown to have excellent performance in a multicenter study of over 10,000 average-risk individuals. On the basis of these results, the automated and commercialized Cologuard test was approved simultaneously by the US Food and Drug Administration and the Center for Medicare and Medicaid Services on August 11, 2014. Informed by the validation data and rigorous regulatory approval process, we propose minimum standards for regulatory stringency, quality control, and test performance for future assessment of noninvasive CRC screening tests.

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Abbreviations

ACO:

Accountable care organization

CLIA:

Clinical Laboratory Improvement and Amendment

cm:

Centimeter

CMS:

Centers for Medicare and Medicaid Services

CRC:

Colorectal cancer

DeeP-C:

Multi-target colorectal cancer screening test for the detection of colorectal advanced adenomatous polyps and cancer

DNA:

Deoxyribonucleic acid

FDA:

Food and Drug Administration

FIT:

Fecal immunochemical test for hemoglobin

IDE:

Investigational device exemption

MT-sDNA:

Multi-target stool DNA test

NCD:

National coverage decision

NCQA:

National Committee for Quality Assurance

PMA:

Premarket approval

QuARTS:

Quantitative allele-specific real-time target and signal amplification

sDNA:

Stool DNA

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Authors and Affiliations

  1. Division of Gastroenterology and Hepatology, Mayo Clinic, 200 First Street SW, 55905, Rochester, MN, USA

    David A. Ahlquist

  2. Department of Internal Medicine, Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA

    John B. Kisiel

Authors
  1. David A. Ahlquist
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Correspondence to David A. Ahlquist .

Editor information

Editors and Affiliations

  1. Department of Gastroenterology, Minneapolis VA Medical Center, Minneapolis, Minnesota, USA

    Aasma Shaukat

  2. Department of Medicine, Yale University, New Haven, Connecticut, USA

    John I. Allen

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Ahlquist, D., Kisiel, J. (2015). Stool DNA for Colorectal Cancer Screening: From Concepts to Quality Care. In: Shaukat, A., Allen, J. (eds) Colorectal Cancer Screening. Springer, New York, NY. https://doi.org/10.1007/978-1-4939-2333-5_6

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  • DOI: https://doi.org/10.1007/978-1-4939-2333-5_6

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