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

Description

PROJECT SUMMARY Rapid saliva test for diagnostics of Neuro Cognitive Disorder due to TBI The goal of this Phase II SBIR project is to develop a rapid saliva test for diagnostics of Neuro Cognitive Disorder due to Traumatic Brain InjuryNCDTAboutTBI patients develop NCDTa serious chronic diseaseStandard NCDT diagnosis is based a battery of neuropsychological tests administered in hospitalWeaknesses of the standard practicenot objectivelow accuracyhigh cost and inconvenienceThe proposed project will develop rapid commercial test for NCDT diagnostics in point of carePOCThe commercial test will be a disposable lateral flow immunoassayLFIAbased on innovative technologiesSaliva based NCDT biomarkers andMultiplexed LFIA for whole salivaKey advantages over standard practiceobjectiveaccuratesimple and inexpensive NCDT testPhase I RandD identified Ncandidate NCDT biomarkers with diagnostic accuracyfor NCDTindependent predictorsbaseline concentration rtng ml and fold increase in NCDTfoldSpecific objectives for Phase IISAwill collect Nlongitudinal saliva samples from Npatients in a multi center studyNNCDT and NcontrolsSAwill measurecandidate NCDT biomarkers in saliva samples from SAusinggold standard saliva assays validated in Phase IResults will cross validate the diagnostic accuracy of the biomarkersand down selectbest biomarkers for the commercial NCDT testSAwill develop a prototype commercial LFIA test for measuringNCDT biomarkers in whole salivaThe proposed NCDT test has potential to radically change standard practice in TBI care by providing validobjective NCDT diagnosticsa key element for decisions about return to playstarting interventionand for advancing TBI treatmentThe proposed project has strong commercial potential based on existing team of proven industry partners and tested FDA regulatory path for the commercial device