PathoGenetix, Inc. announced today that it has received the first of six “alpha” prototypes for its new rapid bacterial serotyping and strain typing system, and has begun internal testing of the instrument performance to specifications. Called the RESOLUTION™ Microbial Genotyping System, the fully automated system includes the instrument, bioinformatics software and database, and pathogen-specific assays, and will be commercially available in 2014 for use in food safety testing and foodborne illness outbreak investigations.
The RESOLUTION System is based on PathoGenetix’s proprietary Genome Sequence Scanning technology, initially developed to detect bio-threat pathogens in environmental samples under a five-year, $50-million contract through the Department of Homeland Security. The breakthrough genotyping technology isolates and analyzes DNA direct from complex mixtures—without the need for a pure culture isolate—and provides molecular serotype and strain type information for target bacteria in just five hours. The strain type information provided by GSS is comparable in resolution to pulsed field gel electrophoresis (PFGE), the current gold standard for pathogen identification.
“We are thrilled to reach this milestone in making Genome Sequence Scanning a reality for the food industry and public health agencies,” said PathoGenetix CEO Ann Merrifield. “The RESOLUTION System will dramatically reduce decision-making and response time in pathogen outbreak investigations and tracebacks, when every minute is critical and people’s health and well-being are at stake.”
PathoGenetix’s technology and development partner, Sagentia, will be completing the assembly and testing of the remaining “alpha” RESOLUTION instruments in their Cambridge, UK location, with anticipated completion in May. Over the next three months, PathoGenetix will test, validate and refine the instrument, which includes state-of-the-art optics, microfluidics and robotics. Sagentia will complete the development, coordinate the FCC, CE mark and UL compliance testing for the instrument and finalize the sourcing and manufacture of the instrument components.
The prototype instruments also will be used to verify the RESOLUTION System proprietary software, which detects and analyzes genomic fingerprints against an onboard database of strain fingerprints to determine molecular serotype and strain type. The RESOLUTION System Database will be created using the prototype instruments.
PathoGenetix will use the alpha systems to finalize instrument specifications, and expects “beta” prototype systems to be available in Q4 2013. The company has an agreement to place a beta instrument with one government collaboration partner, and is in discussion with other potential government and industry beta evaluation sites. Performance testing and submission to AOAC of the instrument, assays and protocols is planned for 2014.