The U.S. CDC estimates that each year roughly 1 in 6 Americans (or 48 million people) gets sick, 128,000 are hospitalized, and 3,000 die of foodborne illnesses. The costs in lost productivity and increased health care costs are enormous, in addition to the consequences to individuals and families from missed work and schooling, disrupted family life, and pain and suffering. Reducing foodborne illness by 10% would keep about 5 million Americans from getting sick each year. The U.S. FDA regulates $417 billion worth of domestic food and $49 billion worth of imported food products. And despite U.S. spending of over $2.1 billion per year on food safety testing, the CDC statistics indicate that food safety testing efforts are clearly inadequate. In addition to known pathogens, the growing use of chemicals and antibiotics in the food industry presents significant risks, and the need for detection, prevention, and control of contamination that may be responsible for illness or injury conveyed by foods is ever-growing, with broad impact on public health, in addition to the economic impact. Due to the compelling need for better safety testing methods related to food products, and deficiencies in current methods (lack of low-cost, highly sensitive, high-specificity, real-time multi-analyte portable test methods), Diagtronix proposes to develop a new biosensor platform in this SBIR program targeting food safety testing. The proposed biosensor technology will enable simultaneous detection of multiple contaminants (adulteration chemicals, antibiotics, and pathogens) in food and dairy products rapidly and with low cost. Diagtronix' biosensor technology is designed for portability, consisting of low-cost sensor strips and hand- held reader devices. The proposed Diagtronix' FemtoSensorTM technology (capable of femtoMolar or fM sensitivity) is based on patent-pending Si biochemical fin field effect transistor (bio-finFET, similar to nanowire FETs) intellectual property exclusively licensed from The University of Texas at Dallas (UTD). In Phase 1, Diagtronix aims to establish proof-of-concept for its unique bio-finFET immunoassay technology, for ultrasensitive, rapid, low-cost, and label-free quantification of various food contaminants such as melamine, antibiotics such as streptomycin, and foodborne pathogens such as Staphylococcus. The specific aims of this proof-of-concept study are: Aim 1: Develop both competitive assay and direct detection methods based on different surface functionalization to detect specific, representative contaminants (melamine, streptomycin, and staphylococcus), and evaluate performance. Aim 2: Perform multiplexed tests (on one chip) of three contaminants in raw milk samples and evaluate performance (sensitivity, specificity, dynamic range, and detection time). PUBLIC HEALTH RELEVANCE: The U.S. CDC estimates that each year roughly 1 in 6 Americans (or 48 million people) gets sick, 128,000 are hospitalized, and 3,000 die of foodborne illnesses, resulting in enormous costs due to lost productivity and increased health care costs, in addition to the consequences to individuals and families from missed work and schooling, disrupted family life, and pain and suffering. Due to the compelling need for better safety testing methods related to food products, and deficiencies in current testing methods (lack of low-cost, highly sensitive, high-specificity, real-time multi-analyte portable test methods), Diagtronix proposes to develop a new biosensor platform in this SBIR program targeting food safety testing. The proposed biosensor technology, based on state-of-the art semiconductor manufacturing processes, will enable simultaneous detection of multiple contaminants (adulteration chemicals, antibiotics, and pathogens) in food and dairy products rapidly, with high specificity and sensitivity, and with low cost.