MEDIOMICS, LLC — Department of Health and Human Services SBIR Phase I: R

Description

This proposal aims to develop highly specific rapid and cost effective immunoassays to detect Zika virus ZIKV infection ZIKV is a single stranded RNA virus in the Flaviviridae family that is transmitted to humans through infected mosquitos blood transfusions and sexual contact As of June around Zika Virus disease cases have been estimated in Brazil alone Recently ZIKV has been detected in many other countries including the USA and most European countries The FDA has recently mandated screening the entire US blood supply for ZIKV Key challenges in ZIKV surveillance include the proportion of cases that remain asymptomatic and the nonspecificity of ZIKV symptoms Current methods available for detection of ZIKV are not rapid and furthermore suffer from problems of unreliability and risks of cross reactivity A highly specific easily performed antibody test is urgently needed for both surveillance and patient care Mediomics has developed and commercialized a new assay platform PINCER assays that allows simple homogenous mix and read detection of a variety of targets These rapid result assays can reach high specificity while remaining low cost and easy to use In a recent collaboration with the CDC Mediomics developed a PINCER based homogeneous assay prototype for hepatitis C HCV that achieved specificity sensitivity and inter and intra assay CV s better than These promising analytical parameters combined with the simplicity of homogenous detection indicate a great potential for this assay platform In addition our long term collaborator Dr Tomasz Heyduk s laboratory developed a novel screening platform by combining both ribosome display and Next Generation Sequencing NGS technologies to quickly identify linear and conformational epitopes of antibodies from patient samples We hypothesize that by combining our PINCER platform and the peptide epitopes unique to the ZIKV infection we will be able to develop a specific rapid and cost effective immunoassay for ZIKV detection Toward this goal we have three specific aims in our Phase I project Aim Develop a PINCER based homogeneous immunoassay for ZIKV detection Aim Explore entire protein sequence space of ZIKV to identify peptide ligands specifically recognized by ZIKV antibodies in patient blood samples Aim Optimize and evaluate the performance of both peptide and improved antigen based PINCER assays A third party will perform the evaluation of the prototype assay If this project is successful we should have established a solid foundation for a Phase II project to fully develop and validate a novel immunoassay that is simple mix and read rapid minutes cost effective andlt of ELISA and suitable for low to high throughput screening of ZIKV infection This project is aimed at developing novel immunoassays for Zika diagnosis The improved performance of Mediomics assays relative to ELISA based assays especially increased specificity and reduced cost will assure a large impact on efforts in the detection of Zika virus infection