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

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.

In particular, the company said that it intends to submit its cytogenetic arrays for FDA approval.

"Cytogenetics is one of the first areas where there is interest to move beyond the current research studies, which will require an FDA cleared or approved product," said Andreas Görtz, VP of marketing at Roche NimbleGen, in a statement.

As reported by GenomeWeb Daily News sister publication BioArray News, the FDA last year signaled its intent to increase its oversight over array-based cytogenetic tests.

In addition to Roche NimbleGen, both Illumina and Agilent have announced plans to submit cytogenetic arrays to the FDA for approval.

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