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Genomic Health Comments on New FDA IVD Guidance


NEW YORK (GenomeWeb News) — Genomic Health said today that it has provided initial comment on the US Food and Drug Administration's draft guidance on "In Vitro Diagnostic Multivariate Index Assays."
 
Randy Scott, Genomic Health’s chairman and CEO said in a statement that the “draft guidance represents the first public discussion surrounding the agency's thinking about the regulation of certain laboratory-developed tests."
 
Genomic Health “plans to continue its ongoing dialogue with FDA regarding Oncotype Dx,” the firm’s RT-PCR-based breast cancer prognostic, which the company said went through multiple clinical trials among 2,600 patients.
 
Genomic Health has offered Oncotype Dx as a service through its CLIA-approved lab in Redwood City, Calif since 2004.

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