Research Project
9410400
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 Injury (NCDT). About 30% TBI patients develop NCDT, a serious chronic disease. Standard NCDT diagnosis is based a battery of neuropsychological tests administered in hospital. Weaknesses of the standard practice: not objective, low accuracy, high cost and inconvenience. The proposed project will develop rapid commercial test for NCDT diagnostics in point-of-care (POC). The commercial test will be a disposable lateral flow immunoassay (LFIA) based on innovative technologies: 1/ Saliva-based NCDT biomarkers and 2 / Multiplexed LFIA for whole saliva. Key advantages over standard practice: objective, accurate, simple and inexpensive NCDT test. Phase I R&D identified N=15 candidate NCDT biomarkers with diagnostic accuracy ?80% for NCDT, independent predictors, baseline concentration >10 ng/ml and fold increase in NCDT ?5-fold. Specific objectives for Phase II: SA1 will collect N=2,610 longitudinal saliva samples from N=500 patients in a multi-center study: N=120 NCDT and N=380 controls. SA2 will measure 15 candidate NCDT biomarkers in saliva samples from SA1 using 3 gold standard saliva assays validated in Phase I. Results will cross-validate the diagnostic accuracy of the biomarkers, and down select 3 best biomarkers for the commercial NCDT test. SA3 will develop a prototype commercial LFIA test for measuring 3 NCDT biomarkers in whole saliva. The proposed NCDT test has potential to radically change standard practice in TBI care by providing valid, objective NCDT diagnostics, a key element for decisions about return to play, starting intervention, and for advancing TBI treatment. The proposed project has strong commercial potential based on existing team of proven industry partners and tested FDA regulatory path for the commercial device.
