Development of the Closed Tubule PCR Module

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.