Non-Invasive Clinical Testing Using Biosensors

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DESCRIPTION (provided by applicant): The development of non-invasive clinical diagnostics is a significant goal for improving healthcare. There is increasing awareness that specific diagnostics designed to test saliva and urine may be as predictive as conventional blood tests for many diseases and disorders. Ideally, future testing of saliva and urine will be rapid, quantitative and capable of continuous monitoring when appropriate. Biosensor instrumentation coupled with novel diagnostic assays offers great promise in this area provided there is progress in addressing several technical problems. BioHesion, Inc. will use proprietary protocols in the proposed feasibility research to achieve the following goals: 1) Development of diagnostic tests to quantify total slgA and albumin in saliva and urine using surface plasmon resonance detection. Testing is completed in 10-15min. Total slgA measurements in body secretions will be a requirement for tests to measure specific slgA in Phase II. 2) A significant reduction in biosensor fouling when testing saliva and urine. 3) An increase in the sensitivity of biosensing assays of at least 10-fold. 4) Increased durability of biosensing surfaces to permit repeated use or continuous monitoring of patients. The successful achievement of these goals will facilitate the implementation of mobile instruments capable of quantitative, non-invasive diagnostics at point-of testing. Ultimately, as the trend in sensor miniaturization continues, the robust assays developed in this project will be integrated with tiny sensors capable of continuous in vivo monitoring of patients.