Development of a "High-Throughput Molecular Differentiation Device."

Polymerase Chain Reaction (PCR) is a well-established molecular diagnostic method. The use of PCR for molecular differential diagnosis, however, requires multiplex capability (i.e. the ability to amplify multiple pathogen targets in a single reaction). Genaco has developed a proprietary technology, Target enriched multiplex PCR (Tem-PCR), that allows for specific, sensitive, multiplex PCR and has combined it with the Luminex xMAP technology. The Luminex xMAP technology platform can detect and differentiate up to 100 molecular targets. With the integration of this platform and Tem-PCR, we have established a molecular differential diagnostic system that is capable of detecting multiple microorganisms in a rapid, single assay format. The Genaco Tem-PCR method is highly specific and sensitive and does not require post-PCR cleanup or post-hybridization washes. These features make it possible to fully automate the assays, resulting in a high-throughput system which can analyze hundreds of samples per day. In collaboration with the Centers of Disease Control and Prevention (CDC) and the U.S. Military, Genaco has already successfully developed panels for respiratory infections, encephalitis, foodborne diseases, and hospital acquired infections. For Phase I of this SBIR project, we propose to develop a system that detects up to 20 pathogens that are of military significance.