Pseudo Target Amplification Diagnostics

描述(由申请人提供)：国家过敏和传染病研究所呼吁开发更好的工具来检测和诊断新出现和再次出现的传染病，如流感。需要在护理地点和接近护理地点的环境中，如当地公共卫生部门、不发达国家和任何地方的灾害情况，提供实用和负担得起的检测。这一问题对于人类传染病来说尤其重要，因为没有良好的分子(DNA/RNA)检测可供在护理地点和其他服务不足的地点使用。Alderon Biosciences，Inc.建议开发和测试一种创新的电化学测试方法，用于测量和区分主要健康威胁的流感类型和亚型的病毒RNA。这项技术创新涉及一种基于电化学传感器的高灵敏目标检测的新方法，称为伪靶放大(PTA)。仪器和传感器元件的设计和开发将使病毒RNA测量使用更少的分析时间，更少的步骤，并比目前最新的方法，如实时RT-PCR，更低的设置和每次结果的成本。预期的结果是一种电化学测试技术，它将准确地测量病毒RNA目标，低至100个分子/毫升样本，用于病毒感染的诊断、治疗和控制。初步调查表明，拟议中的技术在研究和公共卫生应用中有很大的市场，在未来三到五年内，随着对更简单、更容易获得和广泛适用的分子工具的需求增加，这一市场将迅速增长，用于测量临床样本中的病毒RNA靶标。 Alderon用于快速和低成本检测病原体核酸的新工具被设想为公共卫生和生物防御应用的强大新工具。它的开发将允许更快速和有效的反应，使世界各地的卫生实验室能够更容易地进行流感诊断和监测，通过更快和更低成本的病原体确定来降低卫生成本。改进对流感的诊断将促进更谨慎和有效地使用抗病毒药物，并避免滥用抗生素。我们估计，eSystem检测系统的近期医学研究和公共卫生市场每年将超过600万美元。

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.