PathoGenetix has delivered an early commercial version of the RESOLUTION Microbial Genotyping System to the US Food and Drug Administration (FDA).
FDA is leasing the system as part of a three-year agreement to evaluate the bacterial identification technology for use in foodborne illness outbreak investigation and response.
The RESOLUTION System, based Genome Sequence Scanning (GSS) technology, enables pathogen serotype identification and strain typing in five hours, from mixtures such as enriched food and clinical samples.
Bacterial strain information provided is comparable to pulsed field gel electrophoresis (PFGE), the current gold standard for pathogen typing, said the firm.
FDA will evaluate the nstrument, reagents and database on food samples collected during food safety audits or foodborne disease outbreak investigations.
It will review and provide feedback to PathoGenetix on capabilities of the technology.