To address the urgent need for better treatment and diagnostic testing of HIV infected people in resource-limited settings, we propose in this Phase II SBIR to further develop an electrochemical testing system (eSystem) developed by Alderon Biosciences, Inc. for determinations of HIV viral load in clinical samples. Alderon's long-term goal is to produce, validate, and gain FDA approval for a facile and affordable (<$10) HIV viral load test, sensitive to below 500 copies/ml, that gives same-day results using an inexpensive and portable instrument. Currently available FDA-approved HIV viral load tests require expensive instrumentation, utilize complex molecular biology procedures, and can cost >$100 per test. Our hypothesis is that Alderon can develop a far more facile and affordable system for accurate viral load measurements and drug susceptibility testing that will enable viral load testing to be done in resource-limited point-of-care (POC) environments. The innovation in the new HIV viral load tests proposed by Alderon lies in the use of advanced electrochemical detection methods for quantifying the activity of reverse transcriptase (RT) in clinical samples. The viral RT enzyme plays an essential role in viral replication, regardless of HIV subtype. Because the enzyme's presence is highly correlated with that of the viral RNA, RT activity assays are a recognized (but not FDA-approved) alternative method for monitoring viral load. Unlike PCR-based assays that have problems quantifying the often-changing RNAs of some HIV subtypes, RT activity tests work equally well for HIV-1 (regardless of subtype) and HIV-2, can be done without highly skilled technicians, and are less subject to problems of contamination. Alderon's Phase I work has shown feasibility of an electrochemical approach to quantification of viral RT activity, with the potential for greatly improved performance (time and cost per test) relative to optical assays. Alderon's proposed 3 year Phase II SBIR project has 4 Specific Aims that will lead to eSystem improvements and accurate detection of HIV load in facile and low-cost same-day tests.
Aims 1 and 2 focus on improvements in the instrument and sensors that will make the viral load assays more affordable and simpler for use in resource-limited settings.
Aim 3 improvements of reagents and assay protocols will further reduce assay time and complexity.
Aim 4 validation of eSystem performance in viral load tests with a wide range of samples will set the stage for FDA approval and product commercialization. Collaborative work with the UNC Center for AIDS Research will establish the correlation between results of eSystem assays and viral load results obtained by alternative FDA- approved methods. Product commercialization will be facilitated by collaborative work with Magellan Biosciences, whose engineering expertise will aid in the development of reliable and robust instruments and viral load test kit components that can be produced in facilities certified for good manufacturing practices.

Public Health Relevance

An estimated 33.2 million people are now living with HIV disease worldwide and in 2007 it claimed the lives 2.1 million people, including 330,000 children (World Health Organization). To address the urgent need for better treatment and diagnostic testing of HIV infected people, Alderon Biosciences, Inc. proposes to further develop a low-cost and easy-to-use electrochemical testing system (eSystem) for determinations of HIV viral load in clinical samples. Alderon's approach will make it possible to perform viral load testing in primary care or point-of-care (POC) environments and aid in monitoring and treating HIV positive patients in resource-limited environments.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
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Special Emphasis Panel (ZRG1-AARR-E (16))
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Fitzgibbon, Joseph E
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Alderon Biosciences, Inc.
United States
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