# Refinement of a rapid saliva miRNA diagnostic test for concussion

> **NIH NIH R42** · QUADRANT BIOSCIENCES, INC. · 2020 · $380,848

## Abstract

Summary/Abstract - Quadrant Biosciences is developing a new diagnostic to aid in the clinical detection of mild
traumatic brain injury (mTBI) in school-aged children and young adults (13–22 years). Based on salivary
microRNA (miRNA) biomarkers, Quadrant’s diagnostic will provide an accurate, objective, and non-invasive
method for mTBI diagnosis. Such a method is critically needed, as the number of pediatric mTBIs is on the rise,
and the developing brains of young patients are more vulnerable to the after-effects of mechanical forces, leading
to a wide range of negative effects on physical, cognitive, and psychological function. The diagnosis and
assessment of mTBI in adolescents are challenging and rely on subjective measures, leading many mTBIs to
go undiagnosed or underreported. This results in suboptimal post-injury treatment and patient management. A
biologic assay to accurately diagnose adolescent mTBI would therefore provide an invaluable guide for clinical
care, potentially guiding decisions for imaging, return to play, return to school, and therapeutic interventions.
While a number of potential biomarkers for objectively detecting mTBI have been proposed, including the blood
biomarkers glial fibrillary acidic protein (GFAP) and ubiquitin c-terminal hydrolase (UCH-L1), recent research
questions the ability of blood-based biomarkers to differentiate patients with mTBI from those with acute
orthopedic trauma, particularly in pediatric populations. Moreover, these assays require venipuncture expertise
that is not always available, particularly in the case of sports-related concussions, which account for nearly 1/3
of mTBIs in this patient population. To address these shortcomings, Quadrant Biosciences is creating a novel,
objective diagnostic tool based on a panel of saliva miRNA biomarkers that are differentially expressed in patients
with mTBI. Pilot studies in over 200 individuals with mTBI have identified a panel of saliva miRNAs capable of
diagnosing mTBI and predicting symptom duration. In the proposed Fast Track project, Quadrant will advance
development of this test by establishing a rapid, accurate method for quantifying these miRNAs and
refining/validating a diagnostic algorithm to differentiate adolescents and young adults with mTBI from peers with
symptomology that mimics mTBI (e.g. chronic headaches, anxiety/depression, ADHD, exercise-related fatigue,
and orthopedic injury). In Phase I, Quadrant will refine a diagnostic algorithm for mTBI using a rapid quantification
technique for saliva miRNAs. Machine learning will be used to develop a diagnostic algorithm that employs
miRNA levels from the rapid multiplex assay alongside participant medical and demographic characteristics to
predict mTBI status. In Phase II, Quadrant will validate the diagnostic algorithm for differentiating mTBI from
medical conditions with overlapping symptomology in a prospective, case-control study of 2500 adolescents and
young adults (age 13–22 years) to ...

## Key facts

- **NIH application ID:** 10081522
- **Project number:** 1R42NS119119-01
- **Recipient organization:** QUADRANT BIOSCIENCES, INC.
- **Principal Investigator:** David Levitskiy
- **Activity code:** R42 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $380,848
- **Award type:** 1
- **Project period:** 2020-09-15 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10081522

## Citation

> US National Institutes of Health, RePORTER application 10081522, Refinement of a rapid saliva miRNA diagnostic test for concussion (1R42NS119119-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10081522. Licensed CC0.

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