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.
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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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