Development of Biomarkers for Clinical Assessment of Occult Infection and Forecasting Emerging Disease Outbreaks

The objective of this proposed SBIR Phase II effort is to develop diagnostic assays based on a set of genetic signatures that provide actionable, sub-species level discrimination, including antibiotic resistance profiles, for high priority pathogens, including occult and emerging varieties. The combination of a universal amplification and labeling system with the beaded array will provide a revolutionary improvement in medical molecular diagnostics with unprecedented fidelity and adaptability to identify occult and emerging disease agents. These assays will have broad applicability in military and commercial settings, as they will enable rapid action needed to reduce mortality, morbidity and treatment costs. We will screen the genetic profiles of up to 100 clinical isolates of Staphylococcus aureus with known antibiotic resistance profiles using a 4,000+ feature planar microarray in order to develop a signature set of high value markers for rapid, treatment-based assays to identify MSSA and MRSA. In parallel, we will develop a multi-signature per organism multiplexed assay for the three major biothreat organisms, Bacillus anthracis Ames, Yersinia pestis, and Franciscella tularensis. These assays will be developed using the Luminex system, which provides the basis for flexible, rapid, low cost diagnostic assays. A respiratory viral panel has been FDA-approved on this platform.