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Opinion and Comment
Nature Biotechnology 27, 420–421 (1 May 2009) | doi:10.1038/nbt0509-420
Regulating laboratory-developed tests
Abstract
To the Editor: As President of the American Clinical Laboratory Association (ACLA; Washington, DC), I am writing on behalf of ACLA members to applaud Nature Biotechnology for clearly delineating why regulation of in vitro diagnostics by the Food and Drug Administration (FDA; Rockville, Maryland, USA) would set back the promise of personalized medicine by years, if not decades. I won't repeat the points made in your March editorial other than to emphasize that the negative consequences of FDA regulation for patients are very real.
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