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Rapid Development of a Highly Specific Dengue Diagnostic Test

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AI141273-01A1
Agency Tracking Number: R41AI141273
Amount: $299,938.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIAID
Solicitation Number: PA18-575
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-03-11
Award End Date (Contract End Date): 2021-02-28
Small Business Information
Miami, FL 33133-5155
United States
DUNS: 079559291
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (305) 243-0405
Business Contact
Phone: (305) 322-4561
Research Institution
CORAL GABLES, FL 33146-2926
United States

 Nonprofit College or University

Project Summary Abstract The advent of the Zika virusZIKVepidemic around the world has and will cause problems for the correct diagnosis of flavivirus infectionsFor many yearsDENV serological diagnosis was relatively straightforwardHoweverafter the recent ZIKV epidemiccross reactive antibodiesAbsgenerated after ZIKV infection will bind to DENV even if the patient has never had DENVThe only FDA approved method to differentiate infection by these related viruses is to carry out the Plaque Reduction Neutralization TestPRNTThis assay is laboriousexpensivenot easily adapted to clinical laboratoriesand the results are often equivocalWe have already faced this problem with diagnosis of new ZIKV infections at our company Z QuickLLCAt Z Quickwe have already solved the inability to distinguish between ZIKVand DENV exposure by using a monoclonal AbmAbcompetition based assayWe planthereforeto isolate broadly reactive DENV specific mAbs and develop a similar highly specificmAb competition based approach for the diagnosis of DENVWe have isolated overanti DENV human mAbs from DENV exposed patients and DENVvaccineesWe will screen these mAbs at the University of Miami for binding propertiesspecificallymAbs that recognize DENV and not ZIKVWe have previously developed a rapid and innovative mAb competition based assay to detect previousZIKV exposure that can discriminate between DENV and ZIKV with extraordinary specificityIf we are successfulwe willEstablish a robustrapidand highly specific test for prior DENV exposure that is not complicated by prior ZIKV infectiontest our diagnostic assay on complexwelldefined human clinical samples so that our assay can be offered immediately as a laboratory developed testLDT!Project Narrative The current standard for serological dengue virusDENVdiagnosis does not have sufficient specificity and sensitivity since the recent Zika virusZIKVoutbreakWe plan to develop a highly specificcompetition based diagnostic test for prior exposure to DENV using monoclonalmantibodiesAbsand patient plasmawhich will overcome the Ab cross reactivity problems that follow ZIKV exposureWe will utilize our already existing library of mAbs isolated from DENV exposed and DENV vaccinated individuals prior to the current ZIKV outbreak to develop this DENV specificcompetition based diagnostic assay

* Information listed above is at the time of submission. *

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