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

Gail Javitt
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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

Nature, 2010, vol. 466, issue 7308, 817-818

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.

Date: 2010
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DOI: 10.1038/466817a

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