BIOPEPTIDES CORP — Department of Health and Human Services SBIR Phase I: NIAID

Description

DESCRIPTION provided by applicant We propose to develop a more sensitive specific multiplex serologic assay for the diagnosis of Lyme disease LD LD is the most common vector borne infectious disease in the United States and as such it is a significant public health concern The disease affects multiple organ systems including musculoskeletal skin and nervous system and is included in the differential diagnosis of multiple diseases In the absence of Erythema migrans the classic skin lesion of early LD the diagnosis is established by the detection of an antibody response to Borrelia burgdorferi Bb in patients with objective findings suggestive of the disease Prompt diagnosis is important because early treatment of LD limits or prevents serious damage to the systems affected Current serodiagnostics lack sensitivity in early disease We laid the ground work for a new generation of seroassays by mapping and defining the specific linear B cell epitopes of key Bb antigens expressed in early infection We identified specific epitopes from of antigens that are suited for use in multi peptide based assays In collaboration with Bio Rad Laboratories we will develop a highly sensitive and specific Luminex r LD serodiagnostic utilizing multiple peptides containing specific linear epitopes key Bb antigens Luminex r X Map is becoming a standard technology in most large clinical diagnostic labs Bio Radandapos s BioPlex is currently used at over locations in the US including commercial clinical labs such as Quest Laboratories and LabCorp large medical groups such as the Mayo and Cleveland Clinics and many University based medical centers Our novel and highly innovative approach will fill the void in LD diagnostics especially in early LD and will provide superior specificity and sensitivity compared to current assays in all phases of LD In addition our collaboration with Bio Rad Laboratories offers a clear cost effective path to the commercialization of this much needed technology PUBLIC HEALTH RELEVANCE Lyme disease the most common vector borne infectious disease in the United States has a wide array of clinical manifestations that are similar to those of other rheumatologic and neurologic illnesses Current laboratory tests are based on twentieth century technology Despite a great deal of effort to improve Lyme disease laboratory tests over the past decades there have been only incremental improvements Laboratory tests measure antibodies produced against spirochetal proteins These proteins can also bind antibodies produced against other bacteria Tests using whole proteins to detect antibodies are not specific We determined the places where antibodies bind to on the different proteins of the Lyme disease spirochete and identified sites that are not similar to those of other bacteria Using this knowledge we are constructing a new test that will limit the problem of nonspecific antibodies This test will be better able to detect antibody produced against the Lyme disease spirochete and less likely to detect antibodies produced against other bacteria