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Regulating laboratory-developed tests

Nature Biotechnology volume 27, pages 419–420 (2009)Cite this article

To the Editor:

You argue in your March editorial1 that the US Food and Drug Administration (FDA; Rockville, Maryland) should keep out of the regulation of genetic tests. The editorial is framed as a reaction to a petition Genentech (South San Francisco, California, USA) filed with FDA last December proposing that the agency regulate genetic tests on the basis of their complexity and risk, not on whether they're produced in-house (with little or no oversight) or as a commercial kit (which means they will have gone through all the available regulatory hoops to ensure public safety).

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References

  1. Anonymous. Nat. Biotechnol. 27, 209 (2009).

  2. Executive order 13497, Fed. Regist. 74 (4 February 2009).

  3. Pollack, A. Quest acknowledges errors in Vitamin D tests. The New York Times 7 January 2009, B1.

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Authors and Affiliations

  1. Genetics and Public Policy Center, Johns Hopkins University, Washington, DC, USA. khudson5@jhu.edu or gjavitt1@jhu.edu,

    Kathy Hudson & Gail Javitt

Authors
  1. Kathy Hudson
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  2. Gail Javitt
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Hudson, K., Javitt, G. Regulating laboratory-developed tests. Nat Biotechnol 27, 419–420 (2009). https://doi.org/10.1038/nbt0509-419b

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