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

Arthur L. Beaudet
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Arthur L. Beaudet: Houston, Texas 77030, USA. abeaudet@bcm.edu.

Nature, 2010, vol. 466, issue 7308, 816-817

Abstract: 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.

Date: 2010
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DOI: 10.1038/466816a

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