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

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.