? We have developed technology known as TIGER (Triangulation Identification for Genetic Evaluation of Risk), which provides a novel and universal approach to the identification of human and animal pathogens. The process uses mass spectrometry, signal processing, and base composition analysis of PCR amplification products from biologically conserved regions of microbial genomes to simultaneously identify the bacterial or viral agents without need for culture. While TIGER technology has been extensively validated and prototype instruments are being deployed to government biodefense laboratories, significant product development tasks must be achieved in order to commercialize the technology for human clinical diagnostics. We propose a cost-sharing model for development and validation of reagent products for identification of a broad range of respiratory and blood-borne infectious agents, including all bacteria and viruses on the NIAID ABC list. Our in-kind contribution will be development of hardware and analysis and control software to create an instrument suitable for clinical laboratory use. The clinical diagnostic system developed here will be a significant advance in human clinical diagnostics that will simultaneously provide national biodefense surveillance on an unprecedented scale. ? ? ?
