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news.NuGEN Technologies, the provider of RNA and DNA amplification and sample preparation technologies for genomic analysis, has received the State of California cGMP certification following an audit process thereby allowing the company to manufacture and ship any of its products under cGMP compliance.
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NuGEN claimed that its cGMP certification, which complements the company’s ISO 13485 compliance, proves NuGEN’s infrastructure and its ability to develop and manufacture reproducible genomic sample preparation products.
NuGEN stated that its diagnostic customer base can begin taking advantage of the company’s cGMP compliance immediately through NuGEN’s pipeline, which enables customers to create and leverage a cGMP-certified version of any NuGEN product.
NuGEN said that by using its 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 FDA 510K clearance.
Erwin Estigarribia, vice president of operations at NuGEN, said: “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 molecular tests in anticipation that they will ultimately deliver personalised treatments for patient diagnosis, disease classification and treatment management for complex and devastating diseases like cancer.
“With our cGMP certification, we’re easing the regulatory burden and shortening the approval timeline.”
Michael Sloan, vice president of business development at Almac Diagnostics, said: “NuGEN demonstrated a capability of working in true partnership with Almac. Their commitment and execution in delivering to our requirements gave us confidence of continued partnership for our future molecular diagnostic tests.”