Electrochemical bDNA probe-based measurement of HIV 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. The need is for tests that are practical and affordable for use in resource poor settings, such as local public health departments in underdeveloped countries, disaster situations anywhere, and areas of military conflict. This problem is particularly important for human immunodeficiency virus (HIV) infections because viral load is strongly correlated with the progression of HIV disease, and in patients receiving antiretroviral therapy, the degree of viral load reduction is the best prognostic parameter for clinical benefit and for sustainability of treatment efficacy. Studies done in resource poor settings where HIV infection rates are highest report that viral load is the most important predictor of HIV transmission between men and women, regardless of the gender of the transmitting individual. Alderon Biosciences, Inc. proposes to develop and test an innovative electrochemical branched DNA assay for measuring and monitoring HIV viral load which is the single best way to predict an infected person's risk of transmitting the virus, for developing AIDS, or dying. The technical approach involves combining the branched DNA signal amplification probes for HIV nucleic acid targets developed by Chiron Diagnostics (Emeryville, CA) with Alderon Biosciences' proprietary nucleic acid diagnostic platform of electrochemical sensors coupled with field-use potentiostats. The instrument and sensor elements will be designed and developed so that HIV viral load measurement will use less assay time, fewer steps, and much lower set-up and per-result cost than the current state-of-the-art nucleic acid probe-based system. The expected result is an electrochemical nucleic acid probe-based assay technology will measure HIV RNA down to 50 molecules/ mL sample in resource poor settings. Preliminary investigation indicates a significant market for the proposed technology in research and public health applications over the next three- to five-year period as the demand increases for simpler, more accessible, and widely applicable tools for molecular assays to measure clinical samples for viral load in the diagnosis, treatment, and control of infections such as HIV.