PROTEOMICS IN DIAGNOSTIC DISCOVERY: LYME DISEASE

The mission of Diagnomics, Inc. is to discover specific ensembles of proteins/antigens that will serve as diagnostic markers and to provide recombinant clones to these markers for production of diagnostic kits in partnership or licensing with a third party. Using proteomics and post-genomic technologies, antigens, including strongly antigenic low expression proteins (SALEPs), will be identified and used as recombinant molecules to create sensitive and reliable markers for evaluating patient serum. Lyme disease is an excellent candidate for development of this new discovery paradigm. First, nearly 3 million seroassays for Lyme disease are performed per year and these assays are unreliable, generally lacking sensitivity, specificity and reproducibility. Second, the genome sequence of Borrelia burgdorferi, the etiologic agent of the disease, is known and thus identification of proteins can be performed using mass spectroscopy fingerprinting techniques. Finally, Diagnomics, Inc. has access to large collections of clinical isolates and patient and control sera. In Phase 1 development, we will: 1) Identify antigenic Borrelia burgdorferi proteins by screening 2D gel fractionated clinical isolates by Western blotting with patient and control sera, and identify these immunoreactive proteins by proteomics using MALDI-TOF mass spectroscopy peptide mapping and genomic database search; 2) Prepare recombinant antigens by PCR subcloning into expression vectors; 3) Validate an ensemble of diagnostic recombinant antigens by testing with sera from culture-confirmed Lyme disease patients and control individuals. This validated ensemble will be developed in collaboration with a third party as a serological diagnostic kit for Lyme disease that will be reliable, specific and sensitive.