Roche NimbleGen Commits to GMP and FDA Submission for Microarrays
News Apr 08, 2010
Roche NimbleGen has announced 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.”