Microarray Industry Keeps an Eye on FDA s Approach to Roche AmpliChip | GenomeWeb

Is Roche prepared to focus its considerable resources to test the US Food and Drug Administration’s regulatory framework in order to get its microarrays approved as analyte-specific reagents? That’s unclear, but microarray producers with hopes for penetrating the lucrative in vitro diagnostic and clinical marketplaces are watching closely the company’s response to an FDA letter questioning claims Roche made in launching the AmpliChip CYP450 microarray last month.

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