Oral Fluid NanoSensor Test (OFNASET)

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DESCRIPTION (provided by applicant): The ability to detect and monitor disease states through totally non-invasive means has been an elusive goal for the diagnostic industry. While oral fluid (saliva) is readily available and completely non-invasive, its utility in clinical diagnostics has only recently been demonstrated. Our team at UCLA, and others, has shown that oral fluid harbors the same composition of disease biomarkers as serum, albeit in smaller quantities. The team has also demonstrated, as part of NlDCR's "Development of Technologies for Saliva/Oral Fluid Based Diagnostics" program, a microfluidic-based micro/nano sensor (Oral Fluid MEMS/NEMS Chip [OFMNC]) for the ultrasensitive, ultraspecific detection of oral cancer biomarkers in saliva. This application includes three highly responsive Specific Aims. Aim 1 will develop the "Oral Fluid NanoSensor Test (OFNASET)" as a handheld and easy to use instrument (OFNASE-lNSTRUMENT) and associated microfluidic consumables (OFNASE-CARTRIDGE). This integrated system will enable the simultaneous and rapid detection of multiple salivary protein and nucleic acid targets. Aim 2 will analytically validate the OFNASET according to diagnostic-industry standards. Aim 3 will preliminarily demonstrate the clinical utility of OFNASET for clinical oral cancer screening. The proposed work will culminate with the design of a pre-market approval (PMA) clinical trial to be presented to the FDA in a pre-IDE meeting. Our vision is to improve patient care by speeding the commercialization of saliva-based diagnostics. We believe that our established strategic alliances with GeneFluidics (a leader in bionanotechnology and microfluidics) and Becton Dickinson (the world's fifth largest clinical diagnostic company) will bridge the chasm between technology conceptualization and commercialization and make our vision a reality. For public: This proposal is to achieve the goal of develop, validate and achieve regulatory FDA approval of tools that can be used by dentists and doctors for in-office real time detection of oral cancer using a drop of saliva.