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Norgen Biotek Corporation Achieves Accreditation to ISO 15189:2007 for Molecular Diagnostic Testing and Clinical Trials


10/5/2011 12:50:20 PM

THOROLD, ON, Oct. 5, 2011 /PRNewswire/ - Norgen Biotek Corp.,an innovative Canadian biotechnology company focusing principally on advancing powerful innovations for nucleic acid and protein preservation and purification from all type of specimens for research and molecular diagnostic applications, today announced successful accreditation to ISO 15189:2007 by the Standards Council of Canada (SCC). This ISO accreditation emphasizes our commitment to quality in our laboratory and R&D services. Norgen's scope of accreditation for ISO 15189 will allow the company to provide high quality, competent molecular diagnostic testing for research purposes and clinical trials. Moreover, this ISO certification will be a great benefit to Norgen in obtaining regulatory approval for our various in vitro molecular diagnostic kits which are currently marketed for research use.

This new ISO 15189:2007 accreditation will complement Norgen's current quality certifications to ISO 9001:2008 as well as ISO 13485:2003. ISO 9001:2008 certification indicates our continuing commitment to our quality management system, while certification to ISO 13485 is a requirement for the manufacturing of commercial medical devices including in vitro diagnostic kits. Certification to all three of these ISO standards strengthens Norgen's commitment to uphold the highest quality in manufacturing our best-in-class products for sample preparation as well as our commitment to providing highly competent R&D and diagnostic testing services.

"Currently, we have over a 100 in vitro MDx kits for the detections of all type of pathogens for research use. This latest ISO certification (15189:2007) is critical for taking all of these kits through the regulatory approval process. Also, this certification is a testimony to the high quality products and services that we provide at Norgen Biotek" said Dr. Yousef Haj-Ahmad, President & CEO of Norgen Biotek.

About Norgen Biotek Corp.

Norgen Biotek is a rapidly growing privately-held Canadian biotech company committed to providing innovative products and services to the life sciences and pharmaceutical industry. Norgen continues to develop products for the purification and preservation of nucleic acids and proteins from all types of specimens for applications in R&D as well as in vitro molecular diagnostics. Detailed information about the company is available at www.norgenbiotek.com.

SOURCE Norgen Biotek Corp.



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