With AmpliChip Cleared, Roche Dx Offers Glimpse of Marketing Strategy; Psychiatrists Enthusiastic | GenomeWeb

Now that its CYP450 AmpliChip microarray diagnostic has been safely cleared as an in vitro device by the US Food and Drug Administration, Roche is hinting at the marketing strategy it will use to put the test within reach — or at least on the minds — of clinicians.

This week the FDA finally granted AmpliChip clearance for the second of two genes interrogated by the test, 2C19, around three weeks after clearing the microarray’s 2D6 portion, along with the chip’s reader, made by Affymetrix [see Pharmacogenomics Reporter, 1/6/2005].

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