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EAST SETAUKET, NY, United States

Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 2.07M | Year: 2009

DESCRIPTION (provided by applicant): Lyme Disease (LD) is the most common vector-borne infectious disease in the United States and remains a significant public health concern. The laboratory diagnosis of LD depends on the demonstration of antibodies against Borrelia burgdorferi. Current serologic assays are not specific enough and not sensitive in early LD. New assays are needed and we plan to fill this unmet need. Our main objective is to produce new sensitive and specific peptide based assays for the serodiagnosis of LD. In Phase I we made excellent progress in defining components for a new serologic assay: we developed IR6 peptides with a broader ability to detect antibody reactivity among patients infected with spirochetes expressing different VlsE sequences; of the 17 known US OspC groups we have identified four (B, F, I, and K) as potential targets for epitope mapping; and we evaluated the ability of a multi-antigenic peptide comprised of sequences from OspC (10 residues), FlaB (13 residues) and VlsE-IR6 (17 residues) to bind antibody from individuals with LD. In this Phase II proposal, we will further optimize the peptides containing epitopes from OspC, FlaB and IR6 and will validate new immunoassays in both ELISA and rapid lateral flow point-of-care (POC) formats. An assay with greater specificity and improved sensitivity for detection of B. burgdorferi antibodies in the earliest stages of the disease, could lead to the development of a single-tier test capable of replacing the currently recommended two-tier paradigm. More importantly, given that early diagnosis and treatment of LD prevents illness progression and sequellae, the development of this test will make an important contribution to improvement of human health. PUBLIC HEALTH RELEVANCE: Lyme disease, the most common vector borne infectious disease in the United States affects multiple organ systems. Although prompt diagnosis and treatment prevents or limits serious injury to the systems affected, current sero- diagnostics for Lyme disease lack sensitivity in early disease and are not specific enough to be used alone. Our objective is to replace today's assays with a new multi-antigen peptide test. Because of greater specificity and improvement to the assay's sensitivity, this approach could lead to the development of a single tier assay to detect antibodies against any of the three pathogenic genospecies ofB. burgdorferi in both early and late Lyme disease.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 151.78K | Year: 2016

DESCRIPTION provided by applicant Lyme disease caused by infection with Borrelia burgdorferi is the most common vector borne infectious disease in North America and Europe Early disease can be effectively cured with antibiotics however untreated late disseminated infection can result in permanent damage to the nervous and musculoskeletal systems Therefore early diagnosis is critical for ensuring good patient outcomes The laboratory diagnosis of Lyme disease is dependent upon the serological detection of antibodies against B burgdorferi However the sensitivity of current IgM and IgG Lyme disease serodiagnostic assays seldom exceeds for the detection of early disease More effective diagnostic assays are needed Serodiagnostics utilizing synthetic peptides have demonstrated significant improvements in sensitivity and specificity for the detection of early Lyme disease The focus of this application is the development of a rapid point of care POC device that utilizes an assay target consisting of a mixture of synthetic peptides that are highly specific for proteins expressed by B burgdorferi during early infection A multi peptide POC assay would offer the benefits of high specificity from the use of peptides unique to B burgdorferi elevate sensitivity from the use of peptides from multiple Bb antigens and rapid diagnosis A POC assay would also improve upon existing conventional assays by reducing the time of accurate diagnosis to a few minutes rather than several days This would improve patient outcome by reducing the likelihood of developing potentially debilitating late stage disease through early antibiotic intervention PUBLIC HEALTH RELEVANCE The CDC estimates that there are Lyme disease cases per year in the United States http www cdc gov lyme stats humanCases html Lyme disease is clinically progressive and if left untreated can result in debilitating permanent damage to the nervous and musculoskeletal systems Early diagnosis and treatment is critical to avoiding disease progression however current diagnostic assays are often unable to detect early disease The focus of this application is the development of a sensitive and specific point of care assay that will provide immediate serological detection of antibodies against Borrelia burgdorferi the causative agent of Lyme disease to aid in physician diagnosis Accurate rapid diagnosis will improve patient outcomes by reducing the likelihood of developing potentially debilitating late stage disease through early antibiotic intervention


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 176.28K | Year: 2016

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


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 605.37K | Year: 2016

Project Summary Lyme disease is a progressive disease that in later stages can lead to debilitating permanent damage to the nervous and musculoskeletal systems Early treatment with an appropriate course of antibiotics is highly effective at clearing infection and preventing disease progression Therefore early diagnosis is critical for ensuring patient outcome However most current IgM and IgG serological assays are not sensitive enough to detect disease at the time most patients seek medical attention More effective alternatives are necessary A T cell based cytokine release assay offers a unique and innovative alternative to serological assays Unlike antibody responses which may remain elevated for years after pathogen clearance the T cell response rapidly wanes with the cessation of effector function and a collapse in T cell numbers Thus monitoring the T cell activity may provide a more sensitive measure of active disease and pathogen clearance than serum antibody responses In phase I we identified unique peptides derived from several antigens expressed by Borrelia burgdorferi during the course of human disease Using a mixture of peptides from four of these antigens we generated a prototype assay that induced detectable secretion of IFN following overnight stimulation of whole blood obtained from patients with well characterized early Lyme disease and observed that IFN secretion was significantly decreased in the same patients days after antibiotic therapy indicating successful clearance of the bacteria These data demonstrate concrete proof of principle that a cytokine release assay for the diagnosis of early Lyme disease can be created and can be successful In this phase II application we will optimize this assay by selecting additional peptide epitopes that stimulate release of IFN from T cells activated in response to infection with Borrelia spp confirming specificity by evaluating samples from patients with potential cross reactive illnesses and evaluating the performance of a QuantiFERON like test before and after treatment of all stages of Lyme disease This will result in the creation of a finalized cytokine release assay for Lyme disease for FDA submission Project Narrative Lyme disease is a progressive disease that can result in debilitating permanent damage to the nervous and musculoskeletal systems if appropriate treatment is not administered at the early stage Unfortunately current laboratory tests for Lyme disease are not very sensitive during early disease and cannot determine if antibiotic treatment was effective We are developing an innovative diagnostic assay that measures the response of T lymphocytes specific for the bacteria that causes Lyme disease Borrelia burgdorferi rather than measuring antibody levels This test is both highly sensitive and highly specific for the detection of disease and can also distinguish between individuals that currently have Lyme disease vs those that had it previously and can determine if treatment was successful


Patent
Biopeptides, Inc. | Date: 2015-08-06

The present invention relates to vaccines for control of

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