Recombinant Based Elisa--diagnosis of Lyme Borreliosis

Period of Performance: 09/30/1995 - 06/30/1996

Unknown

Phase 1 SBIR

Recipient Firm

Brook Biotechnologies, Inc.
Stony Brook, NY 11790
Principal Investigator

Abstract

Current ELISA assays for Lyme disease have a poor positive predictive value. Because of this and pending the development of improved methodologies, the Center for Disease Control recently issued new guidelines that all positive and equivocal B. burgdorferi serologic tests should be confirmed by Western blot.The goal of this proposal is to develop a sensitive. highly specific ELISA based serologic assay that will eliminate the need for Western blot confirmation. Investigators from the Lyme disease Center at SUNY at Stony Brook in collaboration with investigators at Brookhaven National Labs over the past several years have been successful in identifying, sequencing, cloning and expressing key antigens of B. burgdorferi sensu stricto, including OspA, OspB OspC p4l, p66, p73 and p93. By mapping epitopes on these proteins, the sites of specific epitopes have been identified, and unique recombinant chimeric proteins containing these specific epitopes are being produced.To develop these unique proteins into viable products, Brook Biotechnologies, Inc. was formed. Brook Biotechnologies, Inc. has the exclusive license from New York State for the use of these unique chimeric proteins and will utilize these proteins to develop new serologic assays. PROPOSED COMMERCIAL APPLICATION: In the US, over 2 million tests for Lyme disease are performed each year. However, a key problem with the ELISA based assays currently on the market is their high rate of false positives and the resulting poor positive predictive value. This has prompted the Centers for Disease Control to establish interim recommendations which state that all equivocal and positive ELISAs must be confirmed by Western blot. A new highly specific ELISA based assay is needed and will offer significant advantages, particularly less labor, easier interpretation, and reduced cost.