Printed Disposable Sensor for Quantitative HIV RNA Measurement of Viral Load

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DESCRIPTION (provided by applicant): The National Institutes of Allergy and Infectious Disease have called for better tools for the detection and diagnosis of emerging and re-emerging infectious diseases. In response to this need, Alderon Biosciences proposes research to develop printed disposable sensors for quantification of HIV RNA in resource-poor settings. Our research is important for developing sensors for monitoring HIV infected patients because viral load is strongly correlated with the progression of HIV disease and the degree of viral load reduction is the best prognostic parameter for clinical benefit and for sustainability of treatment efficacy. Studies show that viral load is the most important predictor of HIV transmission between men and women, regardless of the gender of the transmitting individual. Our technical approach is to combine signal amplification probes for HIV-specific nucleic acid targets with Alderon's proprietary nucleic acid diagnostic platform using electrochemical sensors and low-cost handheld readers. We will do small business innovation research on printed disposable sensors and measurement technologies that will use less assay time, fewer steps, and much lower set-up and per- result cost than alternative technologies. Major milestones are to create probe-based sensors to measure HIV RNA targets to below 100 molecules/mL with less than 10% false negatives and less than 10% false positives. Market studies indicate a significant market for the proposed technology, which will be addressed through partnerships with larger bioscience companies. To our knowledge, only Alderon Biosciences is developing a technology capable of carrying out accurate, low-cost viral load assays that can be used in "real time" in essentially any public health setting. If successful this project will provide superior pathogenic, biochemical and viral load testing to the market. Alderon Biosciences proposes to develop innovative electrochemical instruments, sensors and assays for measurement of HIV viral load in resource-poor settings. Measurement of HIV viral load is used to guide therapy for infected persons, and therapies that reduce viral load may provide a means of controlling the AIDS epidemic. The proposed assays and test system to measure and monitor HIV viral load will be designed for application in the US and in resource poor settings to provide prognostic information that can help guide treatment decisions and enable public health workers to better prevent the spread of contagious disease.