Development of the Closed Tubule PCR Module

描述（申请人摘要）：目前还没有单一的完全 用于基于PCR的分子诊断的自动化方法。因此，发现和 分子生物学的发展到达临床医生非常缓慢， 缺乏适合护理点市场的诊断工具。在这里我们建议 一种小型化闭管聚合酶链反应的发展 （ct-PCR）模块，其使用适合于便携式， 手持式热循环装置。ct-PCR模块包含小管 流动室技术（TFT），一种微流体机械系统， IVD测试的开发，热循环仪的功能， 用于分子诊断和研究应用的创新系统。我们预计 完全开发的ct-PCR技术，作为一个非常快速的独立 热循环装置或作为用于完全自动化诊断的模块 结合样品制备和直接PCR产物检测系统 模块。这种设备将具有成本效益，易于使用，非常快，能源 高效，并适用于“插入和测试”的分子诊断测试。 拟定商业应用： 基因组学、药物基因组学和遗传学领域最近和持续的信息爆炸， 生物标志物的发现为分子诊断提供了多种潜在的靶点 试验. 目前的限制和挑战是创建一个易于使用、准确、快速 和无生物危害的分子诊断检测平台，适用于大型临床 实验室和护理点。 建议的手持式、电池供电、便携式 ct-PCP模块将以具有成本效益的方式填补这一空白，并在 环境和军事测试。

DESCRIPTION (Applicant's abstract): Currently there is no single fully automated method for PCR-based molecular diagnostics. Thus, the discoveries and developments in molecular biology are very slow to reach the clinician due to a lack of suitable diagnostic tools for the point-of-care market. Here we propose the development of a miniaturized closed tubule polymerase chain reaction (ct-PCR) module, which uses a closed reaction tubule that fits into a portable, hand held thermal cycling device. The ct-PCR module incorporates tubule flow-chamber technology (TFT), a micro-fluid mechanical system currently under development for IVD testing, with thermal cycler capabilities resulting in an innovative system for molecular diagnostic and research applications. We expect the fully developed ct-PCR technology to function as a very rapid stand-alone thermal cycling device or as a module for a completely automated diagnostic system in conjunction with sample preparation and direct PCR product detection modules. This device will be cost-effective, easy to use, very fast, energy efficient, and suitable for "insert and test" molecular diagnostic testing. PROPOSED COMMERCIAL APPLICATION: The recent and continuing information explosion in genomics, pharmacogenomics, and biomarker disocvery has generated multiple potential targets for molecular diagnostic tests. The current limitation and challenge is to create an easy to use, accurate, rapid, and biohazard-free molecular diagnostic testing platform appropriate for the large clinical laboratories and point-of-care sites. The proposed hand held, battery powered, portable ct-PCP module will fill this niche in a cost-effective manner and open new markets in environmental and military testing in the near-term.