RECOMBINANT ELISA & IMMUNOBLOT ASSAYS FOR LYME DISEASE

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The long term objective of this project is to produce recombinant-based diagnostic assays that will improve the accuracy and reduce the cost of testing for Lyme Disease. Having demonstrated that recombinant chimeric proteins containing immunodominant Borrelia burgdorferi antigens can detect Borrelia-specific antibodies in sera from clinically well defined Lyme disease patients with improvement in both sensitivity and specificity, Brook Biotechnologies proposes to develop commercial test kits based on these chimeric proteins. The approach proposed is first to characterize ELISAs based on a combination of two chimers; second to standardize and validate GMP processes for producing commercial assay kits; third to test the capabilities and limitations of the commercial form of the kits based on FDA guidelines; fourth to develop, standardize and validate a one-step immunoblot assay based on recombinant proteins and/or chimers. The studies proposed will support a 510(k) submission to FDA in Phase III, leading to registration and approval to market the products in the US. PROPOSED COMMERCIAL APPLICATION: The Phase II research program will produce most of the data required to support a 510(k) submission with FDA for approval to market the recombinant ELISA and immunoblot tests. Brook Biotechnologies expects to file this document at the end of 1998 and to begin marketing the products in 1999. There are greater than 5 million ELISA tests and greater than 500,000 iminunoblot tests for Borrelia infection performed annually in the US, and the market is expected to continue to grow.