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February 17, 2015

Genetic Testing and FDA Regulation: Overregulation Threatens the Emergence of Genomic Medicine

Author Affiliations
  • 1Departments of Genetics and Medicine, University of North Carolina at Chapel Hill
  • 2American College of Medical Genetics and Genomics, Bethesda, Maryland
  • 3ACMG Foundation for Genetic and Genomic Medicine, Bethesda, Maryland
JAMA. 2015;313(7):669-670. doi:10.1001/jama.2014.18145

Should the FDA regulate laboratory-developed diagnostic tests? —No.

In November 2014, the US Food and Drug Administration (FDA) revealed its intent to regulate thousands of medical diagnostic tests being performed in as many as 11 000 clinical laboratories throughout the United States, focusing especially on genomic medicine.1 Although the FDA is well intentioned, the current plan for regulation is unnecessary and, if carried out, could result in the closure of many laboratories, undermine innovation, and potentially limit patient choice. Moreover, the proposed regulation, if unchanged, is likely to lead to thousands of laboratory submissions to the FDA, for which its own staffing capacity is tenuous at best. If implemented, the requirements may have the unintended effect of derailing the long-awaited emergence of genomic medicine.

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