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.
