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Which way for genetic-test regulation? Leave test interpretation to specialists

Nature volume 466, pages 816–817 (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 first of two related pieces, Arthur L. Beaudet advocates the US Food and Drug Administration banning direct-to-consumer medical tests but leaving the analysis of clinical diagnostics to specialists. In the second, Gail Javitt argues that the agency should implement a regulatory framework for all health-related tests.

Several regulatory agencies are gearing up to control at least some aspects of genetic testing. In the United States, the Food and Drug Administration (FDA) held meetings in June and July on how and what to regulate1,2. In Europe, regulatory authorities and industry lobbyists are pushing to remove an exemption from the European Union directive on in vitro diagnostic medical devices. This currently allows institutions to design, produce and validate the performance of their own tests.

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  1. Arthur L. Beaudet is in the Department of Molecular and Human Genetics at Baylor College of Medicine, Houston, Texas 77030, USA. abeaudet@bcm.edu.,

    Arthur L. Beaudet

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  1. Arthur L. Beaudet
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Competing interests

Arthur L. Beaudet is in the Department of Molecular and Human Genetics at Baylor College of Medicine, which receives revenue from offering genetic laboratory testing.

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Beaudet, A. Which way for genetic-test regulation? Leave test interpretation to specialists. Nature 466, 816–817 (2010). https://doi.org/10.1038/466816a

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