In New Hurdle for Roche Dx, FDA Will Need To Approve Each of AmpliChip s Two Markers | GenomeWeb

Roche Diagnostics’ AmpliChip CYP450 microarray will have to overcome several regulatory obstacles before it can gain market approval from the US Food and Drug Administration. The product must be approved as an in vitro diagnostic device — not as an analyte-specific reagent, as Roche had originally hoped — and data for each test the product performs must first be OK’d by the FDA, according to an agency official.

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