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FDA Evaluating PathoGenetix Platform for Foodborne Pathogen Detection

NEW YORK (GenomeWeb News) – PathoGenetix today said it has signed a collaborative agreement with the US Food and Drug Administration to evaluate the company's technology for use in foodborne illness outbreak investigation and response.

The deal covers the Woburn, Mass.-based company's Genome Sequence Scanning system, which provides pathogen serotyping and strain typing directly from complex mixtures in five hours. According to PathoGenetix, the bacterial strain information provided by GSS is comparable to pulsed field gel electrophoresis, currently the gold standard for pathogen typing in foodborne illness outbreak investigation and response.

Being able to obtain useful data directly from complex mixtures while shortening the time for pathogen subtyping would result in quicker decisions affecting public health, the company added.

The deal announced today will include the assessment of the GSS instrument, reagents, and database on food samples that the FDA typically collects during routine food safety audits or foodborne disease outbreak investigations, PathoGenetix said. It added that FDA bacterial strains of public health interest, such as Salmonella, E. coli, and Listeria, will be added to the GSS pathogen database.

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