DETECTION METHOLOGY FOR MYCOBACTERIA TUBERCULOSIS

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Early, definition 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 specific for Mycobacteria tuberculosis. 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 secreted protein antigens Ag85, 38kDa and 45/47kDa complex of Mycobacteria tuberculosis, the causative agent of tuberculosis, will serve as the initial targets. Phase II studies will apply the technology to obtain bispecific reagents for other targets if necessary, 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. PROPOSED COMMERCIAL APPLICATION 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, Mycobacteria tuberculosis is an excellent target since it is currently on the rise, with much of the increase linked to the AIDS epidemic.