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

Nature volume 466, pages 817–818 (2010)Cite this article

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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.

This summer, the US Food and Drug Administration (FDA) sent letters to several companies that offer health-related genetic testing directly to customers. These missives informed the companies that the tests are medical devices requiring FDA authorization. The agency has stopped short of threatening to block sales, but the implication is clear: the FDA believes the current marketing of these tests to be unlawful.

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Authors and Affiliations

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

    Gail Javitt

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  1. Gail Javitt
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Competing interests

Gail Javitt is counsel for Sidley Austin, which represents a variety of pharmaceutical, medical device, medical professional and clinical laboratory clients who may now or in the future have financial interests in genetic testing.

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Javitt, G. Which way for genetic-test regulation? Assign regulation appropriate to the level of risk. Nature 466, 817–818 (2010). https://doi.org/10.1038/466817a

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