Multiple Foodborne Pathogen Resequencing Microarray-based Diagnostic Assay

Most contemporary diagnostic tests are designed to detect and identify a single particular pathogen if it may be present in a given specimen. Furthermore such assays typically rely upon a short biomarker, or short signature gene sequence element to INDIRECTLY determine if the specimen is or is not present in the specimen. Such assays are inevitably vulnerable to false negative or false positive reports that can have costly implications from poorly informed decisions in critical food safety situations. In distinct contrast the DIRECT determination of multiple gene sequences from one or more target pathogens can provide unequivocal evidence for the presence or absence of multiple pathogens that may be associated with a particular food safety-related specimen. Furthermore such gene sequences, as opposed to a measured signal intensity from a traditional biomarker assay, provide direct information on the specific strains and variants of pathogens that may be detected, and identification in such detail to support forensic epidemiology or tracking of a chain of breakdowns food-safety. The re-sequencing microarray is a DIRECT DNA sequencing technology that is most efficient at providing accurate gene sequences for hundreds of target pathogen genes in each assay. This Phase I project will develop a prototype resequencing microarray-based diagnostic assay for general application in food-safety. If superior assay performance is demonstrated and validated as may be expected, then this prototype assay has excellent potential for commercialization in broad food-safety related applications. The product will demonstrate significantly superior performance compared to traditional microbial culture or more recent molecular diagnostic assays (e.g. PCR).