BOSTON — Now that Roche Molecular Diagnostics and Affymetrix have broken the proverbial dam by weathering a long clearance process with the US Food and Drug Administration to market the AmpliChip, will other drug-metabolism diagnostics start making their way into the clinic, as well?

Using the example provided by Roche's AmpliChip CYP450 microarray and Affy's GeneChip platform, the FDA has produced a guidance document to help companies usher their own drug-metabolism tests through the clearance process more quickly.

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