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Which way for genetic-test regulation? Assign regulation appropriate to the level of risk

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  • Gail Javitt

    (Gail Javitt is a research scholar at the Berman Institute of Bioethics, Johns Hopkins University and counsel at Sidley Austin. gjavitt1@jhu.edu)

Abstract

Although largely unregulated, genetic tests are increasingly used to diagnose conditions, map ancestry or predict disease risk. In this, the second of two related pieces, Gail Javitt argues that the US Food and Drug Administration should implement a regulatory framework for all health-related tests. In the first, Arthur L. Beaudet advocates the agency banning direct-to-consumer medical tests but leaving the analysis of clinical diagnostics to specialists.

Suggested Citation

  • Gail Javitt, 2010. "Which way for genetic-test regulation? Assign regulation appropriate to the level of risk," Nature, Nature, vol. 466(7308), pages 817-818, August.
    • Handle: RePEc:nat:nature:v:466:y:2010:i:7308:d:10.1038_466817a
    DOI: 10.1038/466817a
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    Cited by:

    1. Iyn-Hyang Lee & Hye-Young Kang & Hae Sun Suh & Sukhyang Lee & Eun Sil Oh & Hotcherl Jeong, 2018. "Awareness and attitude of the public toward personalized medicine in Korea," PLOS ONE, Public Library of Science, vol. 13(2), pages 1-14, February.

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