SBIR-STTR Award

The focus of this STTR phase I component is on proof-of-concept studies demonstrating applicability of technical approaches for identificationof circulatory diagnostic markers for infectious disease. Therefore, the primary objective of this project is to determine feasibility of one suchtechnical approach called Proteomics-based Expression Library Screening (PELS), for identification of pathogen-derived proteins shed incirculation (shed proteins) during the process of infection. PELS is a proprietary, fully validated, highly sensitive platform proteome miningtool for discovery of the gamut of protein antigens expressed by any microbe during infection. Specifically, proof-of-concept will bedemonstrated by identifying a panel of proteins unique to virulent Brucella melitensis strain16 M that are shed in murine sera, collected atvarious time points following experiment infection of mice with the cognate pathogen. Phase II studies will involve application of this Phase Ivalidatedplatform technical approach to defining shed proteins in sera of patients infected with Brucella species and Rickettsia prowazekii,and in sera and cerebrospinal fluid of individuals infected with the Venezuelan Equine Encephalitis virus, followed by marker validation anddevelopment of prototype diagnostic assays. Phase III will involve partnered in vitro diagnostic instrument development and validationstudies for FDA approval, and commercialization.

Assays for accurate diagnosis of early stages of infection with biothreat agents, on the day of infection or within a few days of infection, will find wide use in both civilian and military applications These diagnostic assays, which are anticipated to be highly specific and sensitive, will add to the repertoire of tools of hospitals and clinics that serve our armed forces personnel deployed on the front lines in diverse geographical regions of the globe, as well infectious disease clinics that cater to civilian populations world-wide. In addition, such assays for early accurate diagnosis of infections caused by the above biothreat agents with the ability to wreak havoc in both humans and animals, will be very attractive for organizations involved in surveillance efforts for prompt and effective management of infections caused by these pathogens. The commercial market for such dual use diagnostic assays is therefore expected to be global.