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Opinion and Comment
Nature Biotechnology 27, 421 (1 May 2009) | doi:10.1038/nbt0509-421
Regulating laboratory-developed tests
Abstract
To the Editor: As CEO of Clinical Data (Newton, Massachusetts, USA), I fully support your editorial in the March issue outlining the reasons why Genentech's (South San Francisco, California, USA) citizen's petition to surrender all in vitro diagnostics to US Food and Drug Administration (FDA) oversight is not the right approach to validating clinical tests. Immediately after filing of the petition last December, Clinical Data issued a response in opposition, as did the American Clinical Laboratory Association (ACLA).
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