Early, definitive detection of pathogenic agents often is key to effective treatment and full recovery. Although DNA and protein-based detection systems are widely used to detect pathogen and disease markers, a number of systems have limited capacity to rapidly produce reagents specific for existing and emerging new pathogens. The overall goal of the proposed research is to develop a general, non- immunological method to rapidly obtain reagents with high affinity and specificity for detecting protein targets. The approach is based on a recombinant display library that uses biotin carboxylase carrier protein (BCCP) as a scaffold. In Phase I, methods will be developed to assay and combine individual isolates obtained from this library to create bispecific detection complexes. The membrane protein antigen BmpC of Borellia burgdorferi, the causative agent of Lyme disease, will serve as the initial target, and will provide a model for obtaining reagents specific to other pathogens. Phase II studies will apply the technology to obtain bispecific reagents for other targets, incorporate the bispecifics into existing assay formats and test assay effectiveness in clinical samples. Phase III will involve final process development, incorporation into automated diagnostic systems, and application in commercial markets via partnerships with private pharmaceutical diagnostics firms.
Anticipated commercial applications include new confirmatory diagnostic systems with greatly improved specificity and instrument compatibility, new detection reagents for research and clinical applications, and new manufacturing processes for licensing. Research product applications will be commercialized through Promega's own network; clinical product applications will be commercialized through a pharmaceutical partner. Commercially, Lyme disease is an excellent initial target since it is the most common arthropod-borne disease in the United States, with more than 10,000 new cases occurring in the U.S. each year.