Z-Quick, LLC — Department of Health and Human Services STTR Phase I: NIAID

Description

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