An Integrated Optical DNA Detector for Portable PCR

描述(申请人提供)：分子诊断是体外诊断市场中增长最快的部分。几乎所有的分子诊断分析都使用各种扩增技术，如聚合酶链式反应(PCR)，将特定的序列片段扩增到容易检测的数量。然而，许多这些基于核酸技术(NAT)的测试仍然在一个集中的地点进行，而不是像最初设想的那样作为护理点格式执行。样品运输和等待足够的样品启动高通量系统以实现经济高效的使用所需的时间削弱了这些NAT技术的能力。将NAT商业化以用于非集中式实验室的最大问题之一是用于从PCR扩增中检测目标的设备的成本。在过去的几年里，已经发明了许多核酸传感器，并采用了各种光学、声学和电子检测方法。荧光检测一直是主要的检测方法，但它需要复杂的光学检测系统，而且对成本/质量/功率的要求很高。在非实验室的情况下，确实需要将基于扩增的方法与一种简单且经济有效的分子诊断方法结合起来。最近还报道了利用纳米技术的进步进行生物分析的各种方法。包括Lynntech在内的几家公司正在研究使用贵金属纳米颗粒和纳米结构作为生物分子结合事件的光学传感器。使用我们创新的基于金纳米颗粒的核酸检测技术，Lynntech的目标是设计和开发一种多路、灵敏和负担得起的体外诊断系统，以最低的劳动强度在非实验室环境中使用。第一阶段研究成功地展示了在一种新的DNA检测方法中使用金纳米颗粒。这种新方法的独特之处在于它的简单性，便于将其用于低成本的自动化聚合酶链式反应分析。该方法具有低成本的潜力，因为它使用简单的光学探测器，并且比传统的基于微生物的方法快得多。第一阶段的研究还包括组装和测试将与纳米DNA检测(NDD)分析结合使用的硬件的初始工程设计。在这项第二阶段计划中，Lynntech将扩大我们对DNA和金纳米颗粒之间形成的络合物的理解，并将这一知识纳入其中，以进一步优化快速分析。与我们的联盟合作伙伴Genaco Biomedical Products，Inc.提供的创新的高度多路复用的聚合酶链式反应扩增技术相结合，该系统将提供传染病的分子鉴别诊断。成功开发后，NDD检测将扩大基于扩增的分子检测的应用范围，促进其在食品安全、生物武器检测、血液产品快速分析和环境监测等方面的应用。SARS和禽流感等高传染性疾病是全球健康威胁。建立一个非实验室来测试患者和动物，并在现场提供即时结果，可以在很大程度上帮助阻止疾病的传播。分子诊断是体外诊断市场中增长最快的部分。到2010年，美国市场预计将达到37亿美元，这是一个重要的商业化机会。

DESCRIPTION (provided by applicant): Molecular diagnostics is the fastest-growing segment of the in-vitro diagnostics market. Nearly all molecular diagnostics assays use various amplification techniques such as polymerase chain reaction (PCR) to amplify specific sequence segments to easily detectable quantities. However, instead of being performed as a point-of-care format as originally envisioned, many of these nucleic acid technology based (NAT) tests are still performed at a centralized location. The time required for sample shipping and waiting for enough samples to start a high throughput system for cost-effective usage diminishes the power of these NAT techniques. One of the biggest problems of commercializing NAT for non-centralized laboratory is the cost of the device used to detect the target from PCR amplification. Over the past few years, many nucleic acid sensors have been invented with a variety of optical, acoustic, and electronic detection approaches. Fluorescent detection has been the dominating method, however it requires sophisticated optical detection systems, plus they have high cost/mass/power requirements. There is a genuine need to couple amplification-based methods with a simple and cost-effective method for molecular diagnostics in non-laboratory scenarios. Various approaches to exploit advances in nanotechnology for bioanalysis have also been recently reported. Several companies including Lynntech are investigating the use of noble metal nanoparticles and nanostructures as optical transducers of biomolecular binding events. Using our innovative gold nanoparticles based nucleic acid detection technology, Lynntech aims to design and develop a multiplexed, sensitive, and affordable in-vitro diagnostic system for use in non-laboratory settings with minimum labor intensity. The Phase I study successfully demonstrated the use of gold nanoparticles in a novel assay for the detection of DNA. The new method is unique in its simplicity, facilitating its use in a low-cost automated PCR-assay. The method has the potential to be low cost because it uses a simple optical detector and is significantly faster than conventional microbiology based methods. The Phase I study also included assembly and testing of initial engineering designs of the hardware to be used in conjunction with a nanoparticle DNA detection (NDD) assay. In this Phase II proposal, Lynntech will expand our understanding of complexes that form between DNA and gold nanoparticles and incorporate this knowledge to further optimize the rapid assay. Coupled with an innovative highly multiplexed PCR amplification technology from our alliance partner, Genaco Biomedical Products, Inc., the system will provide molecular differential diagnostics of infectious diseases. When successfully developed, the NDD assay will expand the range of applications for amplification based molecular assays, facilitating its use in food safety, detection of biological weapons, rapid analysis of blood products and environmental monitoring, etc. Highly infectious diseases such as SARS and bird flu are global health threats. Having a non-laboratory set up to test the patients and animals and to provide immediate results on location can help stopping the spread of the diseases a great deal. Molecular diagnostics is the fastest-growing segment of the in-vitro diagnostics market. By 2010, a U.S. market of $3.7 billion is expected, representing a significant opportunity for commercialization.