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PathoGenetix and FDA to Evaluate Bacterial Identification System for Use in FDA Public Health and Food Safety Efforts
Date:4/25/2013

ublic health labs monitoring foodborne outbreaks, and in food industry labs conducting ongoing food safety testing and source tracking.

Other microbial identification systems like PFGE, and even new approaches such as whole genome sequencing (WGS), require a cultured isolate as input. Selecting and culturing a bacterial isolate is a complex and time-consuming process that requires experienced microbiology skills, expensive supplies, and multiple days to complete. The cultural independence of GSS™ eliminates the selection bias inherent in other molecular epidemiology tools. It also makes GSS™ compatible with newer pathogen detection methods increasingly used in clinical and food industry laboratories.

The collaboration will evaluate the GSS™ instrument, reagents and database on a variety of food samples typically collected by FDA during routine food safety audits or foodborne disease outbreak investigations. As a part of the collaboration, FDA bacterial strains of public health interest such as Salmonella, E. coli and Listeria will be added to the GSS™ pathogen database.

“The FDA is pleased to have the opportunity to evaluate this technology and its ability to complement our existing pathogen identification systems,” said Dr. Donald Zink, Senior Science Advisor at FDA’s Center for Food Safety and Applied Nutrition.

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About PathoGenetix, Inc.

PathoGenetix, Inc. is a commercial-stage developer of an automated system for rapid bacterial identification from complex samples. PathoGenetix is a venture-backed company that has received more than $50 million in technology development funding from the Department of Homeland Security. The core GSS technology isolates and analyzes DNA directly from an enriched biological sample—without the need for a cultured isolate—and provides results in just five hours, days faster than current methods. GSS has broad applicability in food safety, industrial microbiology, and clinical diagn
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