# Saliva biomarkers for noninvasive diagnostics of acute mTBI in children

> **NIH NIH R43** · GAIA MEDICAL INSTITUTE, INC. · 2020 · $54,300

## Abstract

PROJECT SUMMARY Saliva biomarkers for noninvasive diagnostics of acute mTBI in
children
Pediatric mild TBI (mTBI) is a global health concern. However, there is no standard approach to diagnose
pediatric mTBI. There is unmet need for standard, objective diagnostics of mTBI, a key element for making
decisions about returning to learning and play, and preventing second impact syndrome. The ultimate goal of
this SBIR project is to develop a rapid commercial test for noninvasive diagnostics of mTBI in children. The
proposed Phase I research will provide proof-of-concept for the core technology: saliva biomarkers
with high diagnostic accuracy and specificity for acute pediatric mTBI. Preliminary Studies (N=135
human subjects, 180 saliva samples) identified N=10 candidate saliva mTBI biomarkers in adults and showed
potential to translate the technology for children. The candidate biomarkers were not confounded by time after
injury, mTBI mechanism, CT scan finding, LOC duration, sex and age in healthy controls.
SA1 will collect N=420 serial saliva samples from N=180 children age 8-17. mTBI patients (N=60, GCS=13-15)
will be enrolled in Houston (40 ED patients, age 8-17) and San Diego (20 HS contact sport athletes, age 15-
17). Saliva and clinical outcome measures will be collected from mTBI and OI at T1-T3: ≤ 24h, 7d and 30d
after injury, and at enrollment from healthy controls. Primary clinical endpoint: acute mTBI. Secondary clinical
endpoint: persistent postconcussion symptoms (PPCS) at 30d, and prolonged Return To Play (RTP) ≥30d after
mTBI. Controls (N=120): mild traumatic orthopedic injury without head injury (OI, ED patients and contact
sport athletes), uninjured contact sport athletes (same game as mTBI), healthy pre-season contact sport
athletes and healthy nonathletes. SA2 will measure the existing N=10 mTBI markers in whole saliva samples
from SA1 using two orthogonal, previously validated laboratory saliva immunoassays. ROC analysis will
determine diagnostic accuracy of the saliva markers for acute mTBI. Logistic regression at 95% CI will
determine prognostic accuracy of the markers for PPCS and RTP at T1-T3.
Expected outcomes: Representative and large sample size (180 children across school age, sex, mTBI
mechanism and geography) will provide statistically significant, generalizable clinical data. Orthogonal
laboratory assays will provide cross-validated, quantitative biomarker data. Demonstration of technical
feasibility in SA2 will provide GO criteria for a full biomarker validation and device development in Phase II. If
successful, the project has potential for high impact on TBI management in children by providing novel fluid
biomarkers for mTBI diagnostics, and offering new insights into pathophysiology of pediatric mTBI. Objective
mTBI diagnostics is a key element for making decisions about return-to-play and learning, preventing second
impact syndrome and advancing TBI treatment. The proposed rapid saliva mTBI test for children has a ...

## Key facts

- **NIH application ID:** 10045461
- **Project number:** 3R43HD097039-01S1
- **Recipient organization:** GAIA MEDICAL INSTITUTE, INC.
- **Principal Investigator:** Douglas Chang
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $54,300
- **Award type:** 3
- **Project period:** 2018-09-15 → 2021-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10045461

## Citation

> US National Institutes of Health, RePORTER application 10045461, Saliva biomarkers for noninvasive diagnostics of acute mTBI in children (3R43HD097039-01S1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10045461. Licensed CC0.

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