GAIA MEDICAL INSTITUTE, LLC, THE SBIR Phase I Award, September 2018

PROJECT SUMMARY Saliva biomarkers for predicting outcome in pediatric and adult patients with severe and moderate TBI Traumatic brain injuryTBIis a leading cause of mortality and morbidity around the worldwith increasing incidenceIn the USTBI is a contributing factor toof all injury related deathsPatient with more severe TBI injuriessTBIare more likely to require hospitalization and suffer long term disabilityThere is unmet need for diagnostic and prognostic biomarkers to aid in treatment decisions and outcome prediction in sTBI patientsThe ultimate goal of this SBIR project is to validate saliva biomarkers for noninvasive prognostics of severe and moderate TBIand translate the biomarkers into a commercial testThe proposed Phase I will show feasibility of the core technologysaliva biomarkers that accurately predict neurological outcome atmonths after moderate to severe TBIin pediatric and adult patientsPreliminary studiesNSaliva samples were collected ath after sTBIGCSNageNcandidate markers were identified based on correlation with poor neurological outcome atm after injuryGlasgow Outcome Scale Extended scoreGOSEand diagnostic accuracy for acute sTBIControlsNageED patients without TBI and healthy volunteersshowed specificity of the markers for TBIand potential to translate the technology for childrenThe proposed study will extend the feasibility of saliva biomarkers across age and TBI severitySpecific AimAdult and pediatric TBI patientsNmonth toyears of ageGCS scoreand controlsNorthopedic injury and healthywill be studied at University of Pittsburgh Medical Center and Childrenandapos s National Medical CenterNsaliva samples will be collected athhh after TBI and at enrolment from controlsNeurological outcome will be assessed using GOSE atm after TBI and OIThe proposed sample size will provide andgtstatistical power to validate biomarkers in patients stratified by outcomeage and sexPrimary outcomepoor neurological outcome atm after TBIGOSESecondary outcomemortality at discharge orm after TBISpecific Aimwill measure Ncandidate markers in saliva samples from SAusingpreviously validated laboratory immunoassaysROC analysis will determine prognostic accuracy of individual markers for TBI outcome and diagnostic accuracy for acute TBILogistic regression atCI will show how accurately the markers predictmonth neurological outcome athh andh after TBIExpected OutcomesThis project will demonstrate feasibility of saliva markers for noninvasive TBI prognosticsRepresentative and large sample sizepatients across agesex and geographywill provide statistically significantgeneralizable clinical dataOrthogonal assays will provide cross validated dataDemonstration of technical feasibility in SAwill provide GO criteria for a full marker validation and device prototyping in Phase IIIf successfulthe project has potential for high impact by providing new biomarkers for noninvasive TBI diagnostics and prognosticsand advancing TBI therapiesThe proposed saliva TBI test has a strong commercial potential based on limited competition and existing team of proven industry partners PROJECT NARRATIVE Saliva biomarkers for predicting outcome in pediatric and adult patients with severe and moderate TBI Traumatic brain injuryTBIis a leading cause of disability and deathHoweverthere is no objective test to diagnose TBI and predict recoveryThe ultimate goal of this SBIR project is to develop a rapid saliva test for noninvasive diagnostics and prognostics of TBI in children and adults