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. To meet this need, Alderon Biosciences Inc. (ABI) proposes to develop innovative, low-cost tests with sensitivity adequate for determining HCV viral load. Reliable and affordable HCV viral load tests would aid in detection and treatment of liver disease. HCV is one of the most important causes of chronic liver disease, affecting about 2% of the U.S. population and causing 10,000 to 12,000 deaths annually. Although quantitative molecular assays for HCV RNA are highly advised, the high cost (above $100), technical difficulty and variability of current tests constitute a major problem for HCV diagnosis and treatment. ABI proposes to develop rapid, facile, and lower cost (less than $25) tests to quantify levels of HCV RNA at clinically significant levels without use of PCR that do not require expensive equipment and can be done in physician's offices or regional public health laboratories. The technical approach involves a primer-extension signal amplification method (PESA) and capillary-flow sensor elements for sensitive and facile execution of low-cost tests. The instrument and sensor elements will be designed and developed so that HCV viral load measurements 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. Preliminary investigation indicates a significant market for the proposed technology in research and public health applications over the next 3-to 5-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 HCV.
