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This move to certification comes as Norgen looks to leverage their first-in-class kits and sample preparation expertise to produce diagnostic kits. In particular, Norgen is in the process of transitioning a number of their leading products into nucleic-acid based diagnostic kits. Reliable and simple procedures for isolating DNA or RNA are critical to the sensitivity and specificity of nucleic-acid based diagnostic kits, and Norgen's technology is well positioned to set new standards in the area of diagnostics. Certification to ISO 13485 is a requirement for the manufacturing of commercial medical devices including in-vitro diagnostic kits, thus achieving ISO 13485 certification will greatly facilitate this transition for Norgen.
"We are dedicated to providing our customers with first class sample preparation kits for RNA, microRNA, DNA and protein purification, clean-up and concentration and to provide dedicated and expert support services to our customers and partners worldwide" said Dr. Yousef Haj-Ahmad, President & CEO. "And now with the ISO certification we can transition our first in class kits into diagnostics. The sensitivity and specificity of the diagnostic kit is highly dependent on sample preparation, therefore we are in an excellent position to make this successful transition" 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 has developed technologies and products for the purification of nucleic acids and proteins on both preparative and industrial scales, including ready-to-use chromatography resins and pre-packed chromatography columns. Detailed information about the company is available at www.norgenbiotek.com.
SOURCE Norgen Biotek Corp.
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