*Design target for technology in development. Sample-to-result time has not yet been established through completed clinical validation or regulatory review.
Three Ways to Engage with GLIA
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TBI remains one of the world's most under-diagnosed medical conditions, underscoring the need for rapid, objective diagnostic tools.
TBI affects over 69 million people globally each year. Yet it remains largely invisible — current diagnosis relies on subjective symptom checklists and bulky neuroimaging technology unavailable outside major hospitals.
Clinicians on sports sidelines, military medics in the field, and emergency physicians in regional hospitals are making life-altering decisions with inadequate tools. We're changing that.
How It Works
Collect
Designed for point-of-care use without dependence on specialised central laboratory infrastructure.
Analyse
GLIA's proprietary platform detects and quantifies miRNA biomarkers that signal brain injury.
Know
Receive a target investigational result in approximately 20 minutes, subject to completed device and clinical validation.
Potential applications across assessment, triage, prognosis and longitudinal recovery monitoring, subject to further clinical validation and regulatory clearance.
For sport and Defence verticals; being developed to provide objective biological information that may complement clinical concussion assessment and future return-to-activity decision-making.
Grounded in Rigorous Molecular Science
GLIA's platform combines deep molecular biology research with pragmatic engineering to produce a tool that works where and when it matters most — at the PoC.
Clinical Studies Completed
Five clinical studies completed, including four peer-reviewed publications, with further validation research planned or underway.⁹⁻¹²
Proprietary miRNA Biomarkers
Seven proprietary candidate miRNA biomarkers supported by clinical research across acute TBI, mTBI and longitudinal recovery cohorts. These signals go beyond traditional protein biomarkers, providing objective biological evidence of brain injury and recovery. Unlike subjective cognitive tests, the platform is being designed not to require an individual pre-injury baseline.
PoC Platform
A compact, intuitive handheld device combining novel electrochemical sensing with single-use disposable cartridges. Portable, battery-powered, and built for real-world conditions — from locker rooms to field hospitals.
Regulatory Pathway
GLIA has completed an independent regulatory strategy review and is preparing for FDA Pre-Submission engagement to confirm intended use, predicate suitability, validation requirements and the appropriate 510(k) or De Novo pathway. Australian and European pathways will be progressed under the TGA framework and EU IVDR respectively.
Building a Body of Evidence
GLIA's platform is grounded in rigorous clinical research. An earlier electrochemical proof-of-concept demonstrated correlation with laboratory polymerase chain reaction (PCR) measurements. GLIA is now translating that work into an integrated handheld minimum viable product (MVP) and a manufacturable disposable cartridge. Further validation is underway with leading US biobanks, military special operations, and professional sports organisations. We are assembling the data required to support regulatory submission and clinical adoption across the settings where TBI care matters most.
Clinical Studies
Five clinical studies completed, including acute TBI, mTBI and longitudinal recovery cohorts, with four peer-reviewed publications and further validation research planned or underway.
Peer-Reviewed Publications
Published and unpublished research supporting the biological rationale and diagnostic performance of our miRNA biomarker panel.
Proprietary Biomarkers
Specific miRNA signatures selected for sensitivity to brain injury and biological specificity.
Plasma micro-RNA biomarkers for diagnosis and prognosis after traumatic brain injury: A pilot study.
Micro-RNA levels and symptom profile after mild traumatic brain injury: A longitudinal cohort study.
MicroRNA biomarkers for diagnosis of mild traumatic brain injury and prediction of persistent symptoms: A prospective cohort study.
MicroRNA Biomarkers on Day of Injury Among Patients with Post Concussive Symptoms at 28-Days: A Prospective Cohort Study.
Advancing From Research to Point of Care
Advancing GLIA's clinically supported miRNA biomarkers toward an integrated point-of-care diagnostic platform.
- 01Biomarker DiscoveryBiomarker discovery, clinical research and peer-reviewed publications.
- 02Proof of ConceptElectrochemical proof of concept demonstrating correlation with laboratory PCR.
- 03IP & Regulatory StrategyIP portfolio and regulatory strategy established as a competitive moat.
- 04Defence DemonstrationsSuccessful Defence demonstrations completed.
- 01Integrated MVP DevelopmentIntegrated MVP development combining reader and cartridge.
- 02Cartridge & Assay IntegrationCartridge manufacturability and assay integration.
- 03Analytical ValidationLaboratory correlation and analytical validation underway.
- 04Sporting & Defence PartnershipsFormalise sporting and Defence partnerships.
- 01FDA Pre-SubmissionFDA Pre-Submission to align on the regulatory pathway.
- 02Clinical ValidationClinical validation studies in target populations.
- 03Regulatory SubmissionRegulatory submission for market authorisation.
- 04Scale Up ManufacturingScale up manufacturing for commercial readiness.
Roadmap reflects current priorities and may evolve based on technical, clinical, and regulatory developments.
Partnering with healthcare, defence, sport and industry to bring objective TBI diagnostics to the point of care.
Momentum From Research to Market
GLIA is currently seeking:
- Clinical and biobank partners for validation studies
- Strategic medtech and manufacturing collaborators
- Defence and sports organisations for future field studies
- Investors to support MVP completion and regulatory readiness
A Defensible, Translation-Ready Position
A triple-layer IP strategy: an exclusive worldwide licence covering the foundational miRNA biomarker family, plus two GLIA-owned patent families covering the point-of-care platform and diagnostic/prognostic methods. Existing protein biomarker tests address an important acute CT-triage need. GLIA is being developed as a complementary miRNA platform with potential applications in diagnosis, prognosis and longitudinal recovery monitoring, subject to further validation and regulatory clearance.
TRL 7 Biomarkers
Biomarker programme assessed at TRL 7; integrated device and cartridge development remain in progress.
Granted Patents
Granted across several territories/jurisdictions, protecting the biomarkers.
Proprietary PoC IP
GLIA-owned: electrochemical sensing + disposable cartridge. PCT successfully filed in several territories/jurisdictions.
MOU and Letters of Support
From multiple sporting codes spanning Australia and the US.
FDA Pathway
Precedent set by Abbott TBI clearance.
Three Patent Families — granted and filed
An exclusive worldwide licence over the foundational miRNA biomarker family, plus two GLIA-owned patent families covering the point-of-care platform and diagnostic/prognostic methods.
*Unitary Patent covering 17 EU states, plus validated in Czechia, Spain and the UK. In force through 2035.
Covers GLIA's point-of-care diagnostic platform. Filed 2024; expiry 2044.
Covers diagnostic and prognostic methods for TBI. Filed 2024; expiry 2044.
Comparing Today's Technologies
Existing approaches address fragments of the TBI challenge — from subjective bedside exams to hospital imaging and protein-based bleed triage. GLIA's miRNA PoC platform is designed to cover the full care pathway from injury through recovery, in settings where the standard of care cannot reach.
Standard Clinical Assessment
Symptom-based and subjective assessment of clinical signs and cognition.
- •Subjective and inconsistent; low–moderate sensitivity for mTBI/concussion.
- •High dependence on clinical expertise.
- •Limited for recovery monitoring and return-to-activity (RTA) support.
Imaging (CT / MRI)
CT is essential for identifying acute intracranial bleeding and other structural injury, but conventional CT and MRI may be normal in mTBI/concussion and are not stand-alone tests for concussion.⁷
- •Often normal in mTBI/concussion; limited sensitivity for mild injury.
- •Hospital-based and non-portable; end-to-end access, imaging and interpretation can take hours.¹³˒¹⁴
- •High cost and resource intensity, particularly for MRI.¹⁶–¹⁹
- •Limited outside hospitals and major population centres, often requiring rural and remote patients to travel.¹⁵
Protein biomarker tests and platforms — including Abbott i-STAT TBI
FDA-cleared GFAP and UCH-L1 whole-blood test intended to assist in determining the need for head CT in adults with suspected mTBI presenting within 24 hours of injury.⁸
- •Variable sensitivity for mTBI/concussion; primarily focused on acute injury/bleeding risk.
- •Moderate portability and dependence on clinical expertise.
- •Moderate cost and resource intensity; limited for recovery monitoring and RTA support.
Oculogica
Adjunct to neurological assessment—not a standalone diagnostic; a positive classification may occur with or without concussion.
- •FDA review states performance was not established in certain ocular conditions, ADHD, or intoxication/drug/alcohol influence.
- •Requires dedicated tabletop eye-tracking hardware and trained, physician-directed use.
- •FDA-cleared for assessment within one week of injury; no explicit FDA-cleared return-to-play indication.²⁰⁻²²
BrainScope
Requires a dedicated mobile device and single-use EEG electrode-array headset, with trained-provider use.
- •FDA-cleared Concussion Index is limited to ages 13–25, GCS 15 and assessment within 72 hours; other outputs have different eligibility criteria.
- •FDA-cleared labelling addresses acute assessment, not long-term or cumulative/repeat-injury prediction.
- •Measures EEG-derived electrical and functional parameters rather than circulating molecular biomarkers.²³
Disclaimer
Competitor comparisons are based on publicly available information available as of July 2026. Product specifications, capabilities, indications for use, regulatory status, and commercial positioning may have changed since that date. Data has been compiled from publicly available manufacturer publications, regulatory databases, peer-reviewed literature, and company websites.
Company and product names are trademarks of their respective owners. This comparison is provided for general informational purposes only and is not intended to misrepresent, disparage, or imply superiority over any competing product. Readers should refer to the manufacturers' official documentation and applicable regulatory authorities for the most current information. Any comparison reflects GLIA's interpretation of publicly available information and should not be relied upon as a substitute for independent clinical, regulatory, or commercial evaluation.
Alfred Hospital
CSIRO
Genesys
Macquarie University
ADF and US DoD
NFL organisation
Four Critical Use Settings
Emergency Medicine
Being developed to support rapid triage following head trauma and provide objective biological information that may complement referral and intervention decisions.
Sport & Athletics
Being developed to provide objective biological information at the point of injury that may complement clinical concussion assessment and future return-to-activity decisions.
Military & Defence
Designed to support rapid field assessment of personnel following blast or other head-injury exposure in remote and austere environments.
Regional & Remote/Austere Health
Designed to bring objective brain-injury testing closer to communities where central laboratory and imaging infrastructure may be hours away.
Future expansion: aged care and community health settings.
Partner With Us
The conditions for adoption have never been stronger.
- →FDA precedent demonstrated for TBI clearance.
- →Growing awareness of mTBI and brain health across sport and society.
- →Increased defence focus on blast exposure and Veteran welfare.
- →Expansion of women's sport — and women's mTBI research.
- →Rising demand for rapid diagnostics in regional and remote/austere settings.
Better access for the communities left behind.
Explore the technology.
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Learn how GLIA’s miRNA biomarker platform is being developed to provide objective TBI information in approximately 20 minutes.
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