Pseudo Target Amplification Diagnostics

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DESCRIPTION (provided by applicant): The National Institute of Allergy and Infectious Disease has called for better tools for the detection and diagnosis of emerging and re-emerging infectious diseases such as influenza. The need is for tests that are practical and affordable for use at point-of-care and near point-of-care settings, such as local public health departments, underdeveloped countries, and disaster situations anywhere. This problem is particularly important for human infectious diseases for which good molecular (DNA/RNA) tests do not exist for use at point-of-care and at other underserved locations. Alderon Biosciences, Inc. proposes to develop and test an innovative electrochemical assay for measuring and distinguishing viral RNA of flu types and subtypes that are major health threats. The technical innovation involves a new approach for highly sensitive target detection based on electrochemical sensors that is called Pseudo- Target-Amplification (PTA). The instrument and sensor elements will be designed and developed so that viral RNA measurement will use less assay time, fewer steps, and much lower set-up and per-result cost than the current state-of-the-methods such as real time RT-PCR. The expected result is an electrochemical assay technology that will accurately measure viral RNA targets down to 100-molecules/ mL sample for use in the diagnosis, treatment, and control of viral infections. Preliminary investigation indicates a significant market for the proposed technology in research and public health applications that is rapidly growing over the next three- to five-year period as the demand increases for simpler, more accessible, and widely applicable molecular tools for measurement of viral RNA targets in clinical samples. Alderon's new tool for rapid and low-cost detection of nucleic acids of pathogens is envisioned as a powerful new tool for Public Health and Biodefense applications. Its development would allow more rapid and effective response to enable health labs around the world to more readily carry out flu diagnosis and surveillance, reducing heath costs through faster and lower-cost determination of causative pathogens. Improved diagnostics for influenza will promote more prudent and effective use of antiviral drugs and avoid indiscriminate use of antibiotics. We estimate the near term medical research and public health market for eSystem detection systems to be in excess of $6 million per year.