Commercialization of a Rapid Blood Test for Traumatic Brain Injury

Traumatic brain injuryTBIis a substantial health care issue affecting both civilian and military populationsAlthough extremes of head injury are recognizablemild to moderate TBImmTBIis more difficult to diagnose leading to a need for the identification of circulating biomarkers of brain injury that may facilitate early identificationUsing a rat model of TBI we identified a novel marker of neuronal injuryubiquitinated visinin like proteinubVILIPthat is released into blood rapidly after injuryTo facilitate rapid on field point of carePOCmeasurement of circulating ubVILIPwe developed a lateral flow deviceLFDthat provides detection of the biomarker in less thanmin from a single drop of blood from a finger stickAlthough initial testing in human TBI patients in a small clinical trial in the Emergency Department of the University of Kentucky is promisingwe have observed variability in the lab produced devices related to limited construction capacity that would likely limit further clinical trialsThereforethere is a need for conversion of our lab produced devices to a commercial vendor for optimization of device architecture and production of analytically reproducible devices for future clinical trialsThe aim of the current Phase I STTR proposal is to work with DCN Diagnostics to optimize antibody conjugation and device architecture and to produce prototype devices for comparison to lab produced devices and evaluation of performance characteristics of DCN produced devicesAnalytical performance characteristics for prototype devices to be evaluated include accuracyprecisionlimit of detectionLODlimit of quantificationLOQlinearity of responseconcentration range and device robustnessResults of the analytical validation will be compared to our lab produced devices particularly for LOD and LOQIf successfulthe proposed studies will verify that our lab produced device can transition to a commercial platform to allow analytically reproducible large scale production of devices necessary for larger clinical trials and pave the way for further commercializationTraumatic brain injuryTBIis a substantial health care issue affecting both civilian and military populations and there remains substantial need for development of a point of carePOCdiagnostic tool that will allow rapid identification of patients with mild to moderate TBImmTBIWe recently developed a lateral flow deviceLFDthat quantifies ubiquitinated visinin like proteinubVILIPa post translationally modified neuron specific Casensor protein released into blood following TBIthat was effective in the identification of mmTBI patients from normal controls in a small clinical trialAlthough our preliminary data are promising there is a need to transition our lab produced devices to a commercial platform for optimization and to compare analytical figures of merit for commercial devices relative to our lab produced devices paving the way for larger scale production of analytically reproducible devices necessary for further clinical trials and further commercialization