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