BioArray News/Industry Awaits FDA's Approach to Roche AmpliChip | GenomeWeb

Can Roche convince the US Food and Drug Administration that its micro-arrays should be approved as analyte-specific reagents? That remains to be seen, but microarray producers with hopes for penetrating the lucrative in vitro diagnostic and clinical marketplaces have been watching closely since FDA sent Roche a letter in July questioning its claim that the AmpliChip CYP450 microarray qualifies as an analyte-specific reagent.

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