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Rapid development of a Zika-specific diagnostic test

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AI138720-01
Agency Tracking Number: R41AI138720
Amount: $299,890.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIAID
Solicitation Number: PA17-303
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-03-16
Award End Date (Contract End Date): 2019-08-31
Small Business Information
Miami, FL 33133-5155
United States
DUNS: 079559291
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (608) 265-3380
Business Contact
Phone: (305) 322-4561
Research Institution
CORAL GABLES, FL 33146-2926
United States

 Nonprofit College or University

Project Summary Abstract
Miami has emerged as the US epicenter of the now global Zika virusZIKVepidemicThe consequences of
infection remain to be fully elucidatedbut the probable link between ZIKV infection and fetal developmental
complications raises enormous concern as to the potential impact of ZIKVCurrent emergency use authorizationEUAcommercial assays detect ZIKV RNAthe presence of ZIKV specific IgMand utilize the laborious
Plaque Reduction Neutralization TestPRNTto detect previous exposure to ZIKVPRNT assay results took
as long asweeks to report back to the patient during theoutbreak in Miami and can be equivocal for
ZIKV exposure when patients have had a history of dengue virusDENVDENV is of considerable concernbecause it infects approximatelymillion people a yearis spread by the same mosquito vector as ZIKVand
causes symptoms similar to ZIKVThis serological cross reactivity between ZIKV and DENV is currently causing
significant problems in the ZIKV diagnostic fieldAccordinglyour plan is to develop a highly specific diagnostic
test for the detection of previous exposure to ZIKVFortunatelywe are in a unique position to rapidly develop
this diagnosticWe have isolated anti ZIKV monoclonal antibodiesmAbsfrom human volunteers that only recognizeZIKV and none of the four DENV serotypesWe have used one of these mAbs in a plasma competition
assay to determine previous exposure to ZIKVWe have developed a rapid and innovative assay to detect previous flavivirus exposure that candiscriminate between ZIKV and DENV with extraordinary specificityIn the current Phase I proposalwe willadvance our preliminary research results to create a clinical ZIKV
diagnostic assay for serological reactivity in the convalescent phasetest our innovative diagnostic assay on
well definedcomplex human clinical samplesanddevelop a novel ZIKV diagnostic test to distinguish
between recent and older ZIKV infectionsProject Narrative
Our plan is to develop a rapidhighly specific diagnostic test for prior exposure to ZIKV using mAbs and patient
plasmaThe current gold standard FDA approved Plaque Reduction Neutralization Test for ZIKV diagnosis is
technically demandinglaboriousinvolves live virus and cell culturetakes several days to performand during
last yearandapos s epidemic in Floridapregnant women were waiting up toweeks for their resultsOur test can be
scaled for high volumewith rapid results returned to patients in three days

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

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