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FDA Letter to Roche Questions Marketing AmpliChip as an ASR

NEW YORK, July 10 - The US Food and Drug Administration has sent a letter to the general manager of Roche Diagnostics, in Pleasanton, Calif., to discuss the appropriateness of Roche's marketing of its microarray-based AmpliChip as an analyte specific reagent (ASR) in the US, GenomeWeb has learned.


The AmpliChip, launched in June, was designed by Roche and manufactured by Affymetrix. It is based on cytochrome P450 liver enzymes.


The letter invites the Roche general manager to the FDA offices to talk about this matter. For the full story, see BioArray News and SNPtech Reporter.

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