NuGEN Achieves cGMP Compliance Certification
Certification Enables NuGEN's Molecular Diagnostic Partners to Utilize cGMP Manufactured Reagents, Accelerating Delivery of Molecular-Based Dx Tests
San Carlos, Calif.—June 17, 2010—NuGEN®, the provider of innovative RNA and DNA amplification and sample preparation technologies for breakthrough genomic analysis, today announced it has received the State of California cGMP (current Good Manufacturing Practices) certification following a rigorous audit process. NuGEN is one of the first sample preparation companies to receive this certification, which allows the company to manufacture and ship any of its products under cGMP compliance.
NuGEN's cGMP certification, which complements the company's ISO 13485 compliance, demonstrates NuGEN's unique infrastructure and its ability to develop and manufacture highly reproducible genomic sample preparation products that meet the premium standards required for developing diagnostic tests. As a result, NuGEN eases diagnostic customers' path to integrating sample preparation products into Dx tests and gaining regulatory approval.
"Our focus at NuGEN is to enable new scientific advances from precious biological specimens. By strengthening our product offerings with the cGMP certification, NuGEN supports faster development of cutting-edge molecular tests in anticipation that they will ultimately deliver personalized treatments for patient diagnosis, disease classification and treatment management for complex and devastating diseases like cancer," said Erwin Estigarribia, vice president of operations at NuGEN. "Our products already provide scientists with new tools to access genetic information from previously unexplorable biological samples and with our cGMP certification, we're easing the regulatory burden and potentially shortening the approval timeline."
By using NuGEN's cGMP-certified sample preparation solutions, customers can easily integrate any of NuGEN's products into their diagnostic applications, eliminating the need to independently establish reproducibility, batch-to-batch consistency and robustness during Food and Drug Administration 510K clearance.
"When evaluating reagent partners, we were looking for a company that was dedicated to providing first-class, cutting-edge products," said Michael Sloan, vice president of business development at Almac Diagnostics. "NuGEN demonstrated a capability of working in true partnership with Almac, proven by their commitment to meet the stringent cGMP-certification requirements by our time line and verifying the quality of products we expect and depend on. Their commitment and execution in delivering to our requirements gave us confidence of continued partnership for our future molecular diagnostic tests."
NuGEN's global diagnostic customer base can begin taking advantage of the company's cGMP compliance immediately through NuGEN's unique quality pipeline, which enables customers to create and leverage a cGMP-certified version of any NuGEN product.
NuGEN provides revolutionary RNA and DNA sample preparation technologies that enable life scientists to do more with less. With innovative reagent solutions that are quick and easy to use, NuGEN empowers researchers to prepare genomic samples of any size, from almost any source, regardless of the intended application or technology platform. Committed to advancing the life sciences, NuGEN ensures robust and reproducible results for researchers seeking to predict disease risk and drug response, potentially shortening the path to treatment.
Yan Zhang, Ph.D.
The Racepoint Group on Behalf of NuGEN, Inc.