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

An Opinion to this article was published on 11 August 2010

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.

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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).

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