NuGEN Technologies, Inc., a privately held company that develops and commercializes nucleic acid amplification and labeling systems, announced today that it has been awarded the International Standards Organization’s 13485:2003 certification by TUV SUD, an engineering services firm providing international safety testing and certification services.

ISO Certification 13485:2003 defines standards for design, development, production, and distribution of medical and in vitro medical devices and components. NuGEN was awarded the certification following a rigorous audit of its quality systems established in 2006 to support the company’s customers in meeting mandated regulatory processes.

Certification is recommended for companies doing business in the global medical devices marketplace. Today, NuGEN’s amplification, fragmentation, and labeling solutions enable the biomarker signature discoveries that drive tomorrow’s clinical diagnostic advances.

According to Eileen deFeo, NuGEN senior director of strategic initiatives and management representative for Quality Assurance, “Achieving ISO certification is the ultimate validation of quality systems that ensure customers can confidently include NuGEN products in their programs.”

All NuGEN amplification and target preparation products are manufactured following the now-certified quality systems. They include solutions for FFPE expression profiling (formalin-fixed, paraffin-embedded), exon analysis, and whole blood expression analysis for signature discovery.