GAIA MEDICAL INSTITUTE, LLC, THE — Department of Health and Human Services SBIR Phase II: NIDCR

Description

PROJECT SUMMARY Rapid oral test for Influenza A B diagnostics The goal of this project is to develop rapid oral test for diagnostics of influenza A BInfluenza is a highly contagious viral infection of the respiratory tract that causes disease in millions of people globallyInfluenza outbreaks occur each year and the associated costs in the US exceed $billion annuallyRecentlyeffective antiviral therapy for influenza became availableThe therapy needs to be initiated withindays of symptom onset to be effectivewhich raised the importance of influenza testing in Point of carePOCThe gold standard for objective diagnostics of influenza infection is a laboratory RT PCR assayRapid Influenza Diagnostic TestsRIDTprovide solution for POC diagnosticsRIDTs are disposable immunoassays that detect Influenza A and B antigens in andltminRIDT have major weaknesses limiting their clinical utilityiThe nasopharyngeal swabNPSspecimen is invasive to obtainiiThe sensitivity is lowThere is unmet need for a noninvasive RIDT with high sensitivityThe ultimate goal of this project is to develop oral RIDT that will use whole saliva specimenKey advantages of oral RIDT compared to NPS RIDTNoninvasive sampleSaliva can be collected easilysafely and noninvasivelyThis is a major advantage over NPSin particular for children and seniorsHigh sensitivityOral RIDT has potential for a higher sensitivity than the NPS RIDT because the concentration of detectable influenza antigen in saliva can be increased by lysing saliva epithelial cells to release cell associated viral proteinsThe proposed Phase I study will provide a proof of concept for influenza A immunoassay in saliva sampleSAwill show analytical feasibility of measuring major influenza A antigensNPHA and NAin whole salivaSAwill leverage existing saliva samples from patients diagnosed with influenza A to show feasibility of detecting influenza A antigens in clinical salivaExpected OutcomesThe proposed Phase I SBIR research will demonstrate the feasibility of oral test for influenza diagnosticsThe scientific premise is strong based on recent discovery of high influenza viral load in in patient saliva and buccal cellsDemonstration of technical feasibility in SAwill provide GO criteria for development of a commercial oral RIDT for Influenza A B in Phase IIIf successfulthe project has potential for high impact by providing noninvasivehighly sensitive oral test for influenza diagnostics that will enable immediateeffective treatment decisions in POCThe proposed oral influenza test has a strong commercial potential based on no competition and existing team of proven industry partners PROJECT NARRATIVE Rapid oral test for Influenza A B diagnostics Influenza is a highly contagious infectious disease that affects millions of people each year and can cause severe illness or death in people at risk such as children and seniorsThe goal of this project is to develop oral influenza test that will help patients to get rapid result and effective treatment in doctor s office or community pharmacy