Phase II year
2017
(last award dollars: 2018)
Phase II Amount
$1,444,910
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.
Public Health Relevance Statement: PROJECT NARRATIVE Rapid saliva test for diagnostics of neurocognitive disorder due to TBI (NCDT) Nearly 4 million people in the USA sustain a traumatic brain injury (TBI) each year; one in three TBI patients develops a chronic disease called Neuro-Cognitive Disorder due to TBI (NCDT). The goal of this project is to develop a rapid saliva test for NCDT diagnostics. The NCDT test will be objective, accurate, simple and inexpensive, and will move NCDT diagnostics from hospital to the patient at home.
Project Terms: Admission activity; Agreement; Anxiety; base; Bedside Testings; Biological; Biological Assay; Biological Markers; biomarker panel; candidate marker; Caring; Chronic Disease; Clinical; cohort; commercialization; cost; Data; Decision Making; Devices; Diagnosis; Diagnostic; diagnostic accuracy; diagnostic biomarker; Diagnostic tests; digital; DSM-V; Elements; Enrollment; Foundations; Functional disorder; Goals; Gold; Home environment; Hospitals; hypoxia inducible factor 1; Immunoassay; Immunohistochemistry; Individual; industry partner; injured; Injury; innovative technologies; insight; interest; Intervention; Lateral; Logistic Regressions; Mass Spectrum Analysis; Measures; Mental Depression; Methods; mild traumatic brain injury; Modeling; Multicenter Studies; neurocognitive disorder; neurocognitive test; Neuropsychological Tests; Neuropsychology; Normal Range; Orthopedics; Outcome; Outcome Measure; patient stratification; Patients; Performance; Phase; Play; point of care; POR gene; primary outcome; Production; prototype; Reporting; Research; research and development; Resources; rho; ROC Curve; Saliva; Sample Size; Sampling; secondary outcome; Small Business Innovation Research Grant; Solid; Specificity; Surveys; TBI Patients; Testing; Time; Translating; Traumatic Brain Injury; Western Blotting; Work
