Physical Optics Corporation — Department of Agriculture SBIR Phase I: 8.5

Description

Approximately 47.8 million episodes (one in six Americans) of foodborne illnesses happen each year and result in roughly 128,000 hospitalizations and 3,000 deaths in the U.S. Approximately half of the reported foodborne illnesses occur in children, with the majority occurring in children under 15years of age. The development of reliable and effective methods to detect foodborne hazards (pathogens, microorganisms, chemicals, toxins) is therefore of paramount importance. To address the USDA's need for a field-ready device to rapidly detect foodborne hazards during pre- and post-harvest processing and distribution, Physical Optics Corporation (POC) proposes to develop a novel rapid Foodborne Pathogen Detection (FPAD) system based on POC's established sandwich ELISA and lab-on-a-chip technologies. The system can perform ELISA with reagent volumes <1-mL and <60 min assay time, leading to a significant reduction of costs and technician-hours associated with time-consuming lab testing. The new system design allows for quantitative identification, agnostic sample preparation, process automation beneficial to users with little training, multiplex assay capability, and high portability. In Phase I, POC will demonstrate FPAD feasibility by assembling a benchtop prototype and conducting multiplex immunoassays for detection of three selected pathogens. In Phase II, POC plans to further develop a fully operational FPAD system by enhancing accuracy, reducing costs, increasing ruggedness for use under extreme field environments, improving configurability for customizable assays (including pathogens and biological toxins), and implementing system automation.With POC's FPAD, the nation will have a cost-effective and efficient platform for rapid identification of microbial pathogens and biological toxins from food, water, and other environmental samples, which is beneficial to federal agencies, such as the Centers for Disease Control and Prevention (CDC). Other applications include on-site detection of pathogens during foodborne illness events, use by First Responders for onsite analysis of harmful pathogens in unknown samples, human health, veterinary applications, and food contamination. Its pathogen-detection capability will also be useful in point-of-care diagnostics for bacterial infections in human and animal subjects, screening for environmental toxins, and assessment of the efficacy of sanitary and decontamination procedures.