# Rapid saliva test for diagnosis of mTBI and prognosis of Persistent Post-conccussion Symptoms (PPCS) in children and adults

> **NIH NIH R44** · GAIA MEDICAL INSTITUTE, INC. · 2022 · $832,833

## Abstract

Project Summary
Rapid saliva test for diagnosis of mTBI and prognosis of Persistent Post-concussion Symptoms
(PPCS) in children and adults
Mild traumatic brain injury (mTBI) is a leading cause of mortality and morbidity. Children are at a higher risk
due to high vulnerability of the immature brain to trauma. mTBI is a significant public health concern because
approximately 30% patients develop Persistent Post-concussion Symptoms (PPCS) preventing return to work,
school and sports. Current diagnostic methods for mTBI and PPCS are inaccurate due to lack of standard
diagnostic criteria. There is unmet need for objective biomarker test. The ultimate goal of this SBIR project is to
develop a commercial saliva test for diagnosis of mTBI and prognosis of PPCS. Phase I showed feasibility of
the key innovation: saliva biomarkers for diagnosis of mTBI and prognosis of PPCS in children and adults. The
proposed Phase II study aims to clinically validate the final biomarker for the commercial test and develop a
prototype device showing feasibility of the commercial product. SA1 will collect N=465 serial saliva samples
from N=225 adolescent athletes age 11-21 during a multisite prospective cohort study of mTBI, orthopedic
injury controls (OI) and healthy controls (HC). mTBI will be diagnosed at ≤72h and PPCS at 30d postinjury.
Saliva samples will be collected at ≤72h, 7d and 14d postinjury from mTBI and at enrollment form OI and HC.
The proposed sample size will provide >80% statistical power to obtain statistically significant biomarker data.
SA2 will measure 5 candidate biomarkers in N=1063 saliva samples (N=465 samples from SA1 plus N=598
existing samples from ED patients and adult athletes). Statistical modeling of a Training set of subjects
(N=475) will down select the final marker and endpoint for the commercial test based on best diagnostic and
prognostic performance. The selected marker and endpoint will be validated using a Validation set (N=240)
based on ≥90% accuracy, sensitivity and specificity of mTBI diagnosis and PPCS prognosis in children and
adults. OI will show mTBI specificity. HC will define normal range of marker concentrations and biological
variability. SA3 will develop a prototype lateral flow immunoassay (LFA) for a selected biomarker. Expected
Outcomes: Results will rigorously clinically validate the saliva biomarker of mTBI and PPCS for the
commercial product. Large and representative sample size (N=715 subjects across mTBI mechanisms of
injury, outcome, age, sex and geography) will provide statistically significant, generalizable clinical data.
N=1063 serial saliva samples and analytically validated assays will provide accurate and reliable biomarker
data. The prototype device will show technical feasibility of the commercial test. Overall, this project has high
potential for a wide-ranging impact on TBI care by providing an objective, clinically feasible biological
biomarker of mTBI and PPCS, and translating this innovation into a ...

## Key facts

- **NIH application ID:** 10490332
- **Project number:** 5R44HD097039-03
- **Recipient organization:** GAIA MEDICAL INSTITUTE, INC.
- **Principal Investigator:** Robert J Elbin
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $832,833
- **Award type:** 5
- **Project period:** 2021-09-17 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10490332

## Citation

> US National Institutes of Health, RePORTER application 10490332, Rapid saliva test for diagnosis of mTBI and prognosis of Persistent Post-conccussion Symptoms (PPCS) in children and adults (5R44HD097039-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10490332. Licensed CC0.

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