Roche NimbleGen Seeks GMP Compliance for Arrays as Step Toward FDA Submission | GenomeWeb

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) - Roche NimbleGen said today that it plans to achieve compliance with Good Manufacturing Process standards for its microarrays "followed by subsequent submission for clearance or approval of select array products to the US Food and Drug Administration."

Frank Pitzer, CEO of Roche NimbleGen, said in a statement that the company is in discussions with the FDA "to ensure compliance in our processes and products" in order to market its arrays in the diagnostic market.

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