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PathoGenetix Adds Director of Manufacturing and Begins Production of New Rapid Bacterial Strain Typing System


PathoGenetix, Inc., a commercial-stage developer of an automated system for rapid bacterial strain typing, has hired Paul Krassnoff as Director of Manufacturing. Mr. Krassnoff will develop production and quality assurance systems for the manufacture of the company’s proprietary Genome Sequence Scanning™ (GSS™) System.

GSS isolates and analyzes microbial DNA directly from an enriched biological sample—without the need for a cultured isolate—and provides strain typing results in just five hours. GSS combines two breakthrough technologies—automated DNA-preparation and extraction, and high-throughput single molecule scanning—that have broad applicability in industrial diagnostics as well as clinical diagnostics and research. PathoGenetix is developing its first commercial product for use in food safety testing and foodborne disease outbreak investigations.

“We are pleased to have Paul join us in this pivotal role as we move to field testing of GSS this year, and commercial launch of the instrument in 2014,” said PathoGenetix CEO Ann Merrifield. “Paul’s extensive background in diagnostics R&D and manufacturing will be invaluable as PathoGenetix puts its manufacturing, inventory management and QA systems in place.”

Investigating and Preventing Foodborne Disease Outbreaks

According to a new report from the Centers for Disease Control and Prevention (CDC), between 1998 and 2008 there were over 13,000 foodborne disease outbreaks in the U.S. resulting in more than 270,000 reported illnesses. When a pathogen is detected in a food production facility, or is making people sick in a foodborne disease outbreak, an investigation is undertaken to identify the responsible organism and trace it back to its original source. Current identification methods, however, involve complicated and time-consuming protocols that require a week or more to provide the necessary strain information. In the meantime, serious and costly public health and financial implications can mount with each passing day.

Genome Sequence Scanning bacterial strain typing offers unmatched levels of speed and automation for food industry testing and public health outbreak investigations. GSS is an automated system that extracts and analyzes microbial DNA directly from complex samples to confirm and strain type foodborne pathogens. The strain information provided is comparable to pulsed field gel electrophoresis (PFGE), the current gold standard for pathogen typing in outbreak investigations. The automated platform and simplified protocol require minimal training and ensure consistent, accurate results across laboratories.

“It’s exciting to be part of the launch of the manufactured products for PathoGenetix’s novel diagnostic technology,” Mr. Krassnoff said.

Prior to joining PathoGenetix, Mr. Krassnoff was Sr. Director of Laboratory Operations & Manufacturing at Aushon Biosystems, where he was responsible for the manufacture and quality control of custom multiplexed analytes and the company’s CLIA-certified testing laboratory. With more than 20 years in manufacturing, quality control, project management and R&D in the medical diagnostics industry, Mr. Krassnoff has worked in research ELISA, quality control and OEM operations support at ALPCO Diagnostics, where he was responsible for the successful launch of a new line of 13 products, and in R&D at Genzyme Diagnostics, bioMerieux and Baxter-Dade. Mr. Krassnoff holds a Bachelor of Science in Chemistry from Boston University and a Master of Science in Biomedical Science from Northeastern University in Boston, MA.

About PathoGenetix

PathoGenetix, Inc. (formerly U.S. Genomics, Inc.) is a commercial-stage developer of an automated system for rapid bacterial strain typing from complex samples. Genome Sequence Scanning™ (GSS™) 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. Developed under a five-year, $50-million Department of Homeland Security contract to detect bio-threat pathogens in environmental samples, the core GSS technology has broad applicability in food safety, industrial microbiology, and clinical diagnostics and research. PathoGenetix is developing its first commercial product for use in food safety testing and foodborne outbreak investigations, with availability in 2014.

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