SBIR-STTR Award

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

The objective of this proposal is to develop a novel nucleic acid testing system intended to provide revolutionary benefits to the diagnostics and healthcare industry. The system will enable the less experienced professional to perform more sophisticated nucleic acid testing in a less expensive setting with greater speed. The technical foundation of this product is the lab-in-a-tube platform. This device will automate and integrate all nucleic acid testing steps, including DNA extraction, amplification and detection, within a closed sample tube; thus, reducing test complexity, turnaround time, cost and the possibility of contamination and operator error. In addition, the sample tube is used to directly collect raw biological samples. Rapid extraction and amplification of genomic DNA has been achieved on a prototype of the system in less than 20 minutes. The system has wide reaching applications to SNP detection, genotyping, and mutation detection. This sample-to-answer system is handheld for point-of-care or field use in a variety of environments. It is designed for extended battery operation. We believe that this system will lead the next-generation of tools for pharmaceutical discovery, therapeutics for disease, clinical diagnostics, bio-defense and agricultural and industrial testing. It is planned for commercial introduction in 2004.

Thesaurus Terms:
biomedical automation, biomedical equipment development, fluid flow, nucleic acid amplification technique, nucleic acid purification blood test, histocompatibility typing, miniature biomedical equipment, nucleic acid quantitation /detection, portable biomedical equipment bioengineering /biomedical engineering, clinical research, human subject