MABDX INC. — Department of Health and Human Services SBIR Phase I: NIAID

Description

PROJECT SUMMARY Zika virus ZIKV Flaviviridae flavivirus is a serious emerging threat in the US and world wide creating an urgent need for accurate Point of Care POC diagnostic tests The project goal is to develop two novel complementary FDA cleared k Lateral Flow Immunoassay LFI devices a zNS LFI to diagnose infection early by detecting ZIKV specific epitopes on ZIKV NS zNS a protein released at high levels during viremia and a zNS serology LFI to diagnose past infection by detecting antibodies to ZIKV specific epitopes on zNS The tests will be rapid affordable easy to use at POC and provide patients in developed and developing nations access to actionable diagnostic information Phase I will create novel monoclonal antibodies mAbs that recognize ZIKV specific epitopes on zNS These mAbs will be used to make a prototype zNS LFI that detects zNS with high sensitivity and does not cross react with NS proteins of other common flaviviruses Clinical utility proof of concept will be demonstrated using a new nonhuman primate NHP model of ZIKV infection to show that the zNS LFI can diagnose acute ZIKV infection using easily obtained samples such as blood saliva or urine The NHP model will then be used to test the hypothesis that fetal ZIKV infection is associated with atypical persistent presence of zNS in the blood of infected pregnant females Positive results would be a significant first step to provide pregnant women in ZIKV affected regions with a rapid inexpensive method to diagnose the risk of fetal ZIKV infection Phase II will optimize the prototype zNS LFI and generate more detailed clinical utility data using the CNPRC NHP model Phase II work will also generate analytical and clinical human performance data to support applications for an FDA Emergency Use Authorization EUA to allow immediate use and concurrently an application will be submitted to FDA for k clearance as a POC IVD zNS epitopes validated as ZIKV specific in Phase I will be used in Phase II to make a novel ZIKV specific protein construct as the key detector component in a ZIKV specific zNS serology LFI Analytical and clinical human performance data will then be collected to support applications for FDA EUA and FDA k clearance as a POC IVD to detect past ZIKV infection Development of these ZIKV specific tests will be a significant advance over existing technologies LFI is a proven highly reliable robust and extremely simple diagnostic assay platform well suited for use in resource limited areas bearing the brunt of the current Zika outbreak In contrast all ZIKV diagnostic tests approved to date under FDA EUA are complex and in accordance with EUA must be performed by highly trained personnel using specialized equipment in centralized clinical reference labs Therefore the novel ZIKV specific POC diagnostic tests proposed here will transform current ZIKV diagnostic practices by providing millions of people with immediate access to affordable diagnostic test results even in resource limited settings PROJECT NARRATIVE Zika virus ZIKV Flaviviridae flavivirus is a serious emerging threat in the US and world wide creating an urgent need for accurate easy to use point of care diagnostic tests To meet this need two novel complementary diagnostic tests similar to easy to use home pregnancy tests will be developed one test will diagnose infection early by detecting ZIKV specific proteins in blood saliva or urine and the second test will diagnose evidence of past infection by detecting ZIKV specific antibodies in blood These novel tests will be significant advances over existing technologies and will transform current ZIKV diagnostic practices by providing millions of people with immediate access to affordable diagnostic test results even in resource limited settings