Roche NimbleGen Commits to GMP and FDA Submission for Microarrays

Roche NimbleGen Commits to GMP and FDA Submission for Microarrays


MADISON, Wis., Apr 07, 2010 (BUSINESS WIRE) -- Roche NimbleGen (SWX:RO) (SWX:ROG) (Pink Sheets:RHHBY), announced today a company-wide initiative to implement Good Manufacturing Processes (GMP) for its suite of DNA microarrays. The implementation of GMP will cover the full scope of processes from development through manufacturing and will include all locations. The company plans on achieving GMP compliance followed by subsequent submission for clearance or approval of select array products to the US Food and Drug Administration.

"Roche is dedicated to providing the research, diagnostic, and pharmaceutical markets with the highest quality products possible," said Dr. Frank Pitzer, CEO of Roche NimbleGen. "We have committed our resources to achieving GMP and are continuing our discussions with the FDA to ensure compliance in our processes and products. This will enable us to provide the research and diagnostic markets with the high quality genomic tools and products they require."

As market needs change and progress, the value of the information provided from microarrays has become more interesting for markets outside of basic life science research," stated Dr. Andreas Gortz, VP of Marketing at Roche NimbleGen. "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."

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About Roche Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2009, Roche had over 80'000 employees worldwide and invested almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information:

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SOURCE: Roche NimbleGen

Roche Diagnostics
Dr. Burkhard Ziebolz
Phone: +49 8856 604830
Email: [email protected]
Roche NimbleGen
Kary Staples
Phone: +1 608 218 7623
Email: [email protected]