Development of the Closed Tubule PCR Module

描述(申请人摘要)：目前还没有一个完整的 基于聚合酶链式反应的分子诊断的自动化方法。因此，这些发现和 分子生物学的发展对临床医生来说非常缓慢，因为 缺乏适用于医疗设备市场的诊断工具。在这里，我们建议 一种小型闭合管聚合酶链式反应方法的建立 (CT-PCR)模块，它使用一个闭合的反应小管，可以安装在便携式， 手持热循环装置。Ct-pcr模块结合了小管。 流室技术(TFT)，一种目前正在开发的微流体机械系统 用于IVD测试的开发，具有热循环器功能，导致 用于分子诊断和研究应用的创新系统。我们预计 全面开发的ct-pr技术可以作为非常快速的独立操作。 热循环装置或作为一个模块进行完全自动化的诊断 与样品制备和直接PCR产物检测相结合的系统 模块。这种装置性价比高，使用方便，速度非常快，耗能 高效，适用于“插入和测试”分子诊断测试。 建议的商业应用： 基因组学、药物基因组学和药物基因组学领域最近持续的信息爆炸 生物标记物的发现产生了多个潜在的分子诊断靶点 测试。当前的限制和挑战是创建一种易于使用、准确、快速 适用于大型临床的无生物危害分子诊断检测平台 实验室和护理点地点。拟议的手持式、电池供电、便携 CT-PCP模块将以经济高效的方式填补这一利基市场，并在 近期将进行环境和军事测试。

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.