Point-of-Care · TBI Detection

Making the Invisible Injury Visible.

GLIA Diagnostics (GLIA) is an Australian medtech company developing a fingerstick, micro RNA (miRNA)-based point-of-care (PoC) platform intended to support the assessment and monitoring of traumatic brain injury (TBI). The system is designed to combine a disposable biosensor cartridge with a handheld electrochemical reader, targeting results in approximately 20 minutes.* GLIA's biomarker platform is supported by clinical research and several peer-reviewed publications; integrated device development and field validation are underway.

A finger-prick blood test that measures proprietary miRNA biomarkers using a PoC device to provide objective results in around 20 minutes.*

*Investigational technology in development. Not approved for commercial clinical use.

Clinician collecting a fingerstick blood sample from a young girl
GLIA diagnostic device
Under 20 mins
Sample to clinical result
< 20 min
Fingerstick to Result
7
Proprietary miRNA Biomarkers
TRL 7
Biomarker Readiness
US$1.4M
Non-Dilutive Funding
The Problem

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.

69M+
people suffer a TBI every year globally
70–90%
of all TBIs are classified as mild — where objective diagnosis is hardest and most needed
up to 2 in 3
TBI cases are estimated to go undiagnosed, leaving millions without appropriate care
~37%
estimated accuracy of current TBI assessment (GCS + clinical variables) — leaving many injuries misclassified or missed
USD$60-80B
annual economic burden of TBI in the United States alone
Simple by Design

How It Works

01

Collect

A simple fingerstick blood sample taken at the PoC — no specialised laboratory training required.

02

Analyse

GLIA's proprietary platform detects and quantifies miRNA biomarkers that signal brain injury.

03

Know

Receive an objective, biologically-grounded result within minutes — enabling confident clinical decisions.

One Platform · A Complete Solution
DiagnosisTriagePrognosisRecovery MonitoringReturn-to-Activity (RTA)
Our Technology

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.

Proprietary miRNA Biomarkers

Our platform detects up to 7 specific miRNA signatures validated across 5 clinical studies and 4 peer-reviewed publications. These signals go beyond traditional protein biomarkers, providing objective biological evidence of brain injury and recovery. Unlike subjective cognitive tests, our biological approach requires no baseline testing prior to injury.

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.

The Device

Designed for the Frontline

Compact enough to fit in a medical kit, robust enough for field conditions. GLIA's novel electrochemical sensing and single-use disposable cartridges bring hospital-grade molecular diagnostics to every PoC — supporting a complete solution across the care pathway.

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GLIA Diagnostics handheld point-of-care TBI device
Concept device render — product under development
*Concept device render — product under development
Clinical Evidence

Building a Body of Evidence

TRL 7 — Biomarker Platform

GLIA's platform is grounded in rigorous clinical research. An earlier electrochemical proof-of-concept demonstrated correlation with laboratory PCR measurements. GLIA is now translating that work into an integrated handheld 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.

5

Clinical Studies

Biomarker evidence has been generated across five clinical studies, including acute TBI, mTBI and longitudinal recovery cohorts, with four peer-reviewed publications.

4

Peer-Reviewed Publications

Published and unpublished research supporting the biological rationale and diagnostic performance of our miRNA biomarker panel.

7

Proprietary Biomarkers

Specific miRNA signatures selected for sensitivity to brain injury and biological specificity.

Populations Studied
Concussion & mild TBI (mTBI)Moderate-severe TBISports, military & first-response settings

Partnering with healthcare, defence, sport and industry to bring objective TBI diagnostics to the point of care.

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Commercial Milestones

Momentum From Research to Market

Founded 2015
Exclusive worldwide licence
Five completed clinical studies
TRL 7 biomarkers
Point-of-care engineering underway
Regulatory strategy established
Seeking strategic partners
Competitive Advantage

A Defensible, Translation-Ready Position

Founded September 2015Headquartered in Sydney, AustraliaRegistered in Australia & the USA~10 years of R&D

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 Science

Biology largely answered — focus now on commercial translation.

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.

Granted Patent Portfolio

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.

GLIA#1 · Detection of TBI — granted
PCTPCT/US2015/051518
United States9,605,315 · 10,202,649 · 10,815,529
Australia2015387481 · 2021258088
Canada2,976,347
China201580077882.4
Europe*3274008

*Unitary Patent covering 17 EU states, plus validated in Czechia, Spain and the UK. In force through 2035.

GLIA#2 · PoC Methods — filed
PCTPCT/AU2024/050264
United States19/167,336
Australia2024241465
Canada3,285,814
China202480025341.6
Europe24773695.2
Singapore11202506333P

Covers GLIA's point-of-care diagnostic platform. Filed 2024; expiry 2044.

GLIA#3 · Methods & Reagents — filed
PCTPCT/AU2024/050890
United States19/513,362
Australia2024329035
Canada3,302,442
United Kingdom2606027.7

Covers diagnostic and prognostic methods for TBI. Filed 2024; expiry 2044.

The Competitive Landscape

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.

The GLIA Difference
Enhanced biological sensitivity: miRNA biomarkers linked to injury and recovery processes, not just end-stage protein bleed markers.
True point-of-care: fingerstick, handheld, battery-powered — results in minutes without central laboratory infrastructure.
Full care pathway: extends beyond bleed triage to mTBI, recovery monitoring and return-to-activity (RTA) decisions.
Objective biological output with lower dependence on clinical expertise; works across emergency, sport, defence, community and remote settings.

Standard Clinical Assessment

Symptom-based and subjective assessment of clinical signs and cognition.

Key limitations
  • 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)

Gold-standard structural imaging for intracranial bleeding and structural injury.

Key limitations
  • Often normal in mTBI/concussion; limited sensitivity for mild injury.
  • Hospital-based, low portability; time to result in hours.
  • High cost and resource intensity; limited for recovery monitoring and RTA support.
  • Generally only available in urban centres.

Protein biomarker tests and platforms — including Abbott i-STAT TBI

Protein biomarker test (e.g., Abbott i-STAT TBI), measuring GFAP and UCH-L1 blood proteins.

Key limitations
  • 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

Eye-tracking (EyeBOX®) concussion diagnostic.

Key limitations
  • Reported use may be constrained by significant ocular conditions (strabismus, cataracts, poor acuity); performance may be affected by ADHD or intoxication.
  • Requires dedicated hardware (camera, screen, analysis unit) and clinician training.
  • Evidence for long-term outcome prediction or RTP was limited in the published literature reviewed.

BrainScope

Portable EEG-based brain injury assessment.

Key limitations
  • Requires specialised EEG headset, tablet and trained operator — limiting low-resource use.
  • Evidence for long-term outcome or cumulative / repeat-injury prediction was limited in the published literature reviewed.
  • Assesses functional impairment rather than the underlying biological injury mechanism.

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.

Research, Development and Engagement Network

Alfred Hospital

Clinical research collaboration

CSIRO

Electrochemical proof-of-concept development

Genesys

MVP engineering

Macquarie University

Incubator and innovation ecosystem

ADF and US DoD

Defence research engagement

NFL organisation

MOU and proposed study collaboration
Where It Matters

Four Critical Use Settings

Emergency Medicine

Hospital EDs, Ambulances & First Response

Rapid triage for patients presenting with head trauma. Enables early identification of significant brain injury, supporting faster and more confident referral and intervention decisions.

TriageEDFirst Response

Sport & Athletics

Sidelines, Locker Rooms & Training Facilities

Objective concussion testing at the point of injury (POI) — empowering team medics, physios, and sports doctors to make return-to-play (RTP) decisions backed by biological data.

ConcussionRTPAmateur & Elite

Military & Defence

Operational Deployments & Field Medics

Blast-related TBI (B(TBI)) is a signature injury of modern conflict. GLIA's portable platform enables field medics to rapidly screen personnel in remote/austere environments, guiding duty-of-care decisions.

Blast TBIField MedicsRemote/Austere Deployment

Regional & Remote/Austere Health

Rural Clinics, Mining & Remote/Austere Communities

Where laboratory infrastructure is hours or days away, GLIA brings equitable, rapid brain-injury diagnostics to communities too often left behind — from outback Australia to remote/austere global settings.

Equity of AccessNo Lab RequiredRemote/Austere & Rural

Future expansion: aged care and community health settings.

Get Involved

Partner With Us

Clinical Partners

We're actively seeking clinical and research partnerships to advance validation studies. If you work in emergency medicine, sports medicine, defence settings or with specialised populations — we'd love to collaborate.

Discuss Partnership

Investors & Industry

An Australian-born medtech opportunity at the intersection of neurology, molecular diagnostics, and PoC technology. Headquartered in Sydney, Australia, with a US entity established to support future US programs. With biology largely de-risked at TRL 7 and a dual-layer IP position. GLIA is preparing a private financing round to complete MVP development, advance sensor manufacturability and progress regulatory readiness. Revenue streams include device sales or reagent rental, recurring disposable cartridge/test sales, service and maintenance agreements, and licensing and platform partnerships.

US$1.5M non-dilutive funding securedUS$250K private investment secured
Investment Enquiry
Why Now

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.
Impact & Health Equity

Better access for the communities left behind.

Aboriginal & Torres Strait Islander AustraliansRegional and remote/austere communitiesWomen and girls in sportDefence personnel & VeteransOlder Australians at risk of falls
Your Move

Explore the technology.
Or partner with GLIA.

Learn how our miRNA biomarker platform delivers objective TBI results in under 20 minutes — or start a conversation about piloting, partnering, or investing.

Our TechnologyPartner With Us
Get in Touch

Let's Start a Conversation

Whether you're a clinician, researcher, investor, or industry partner — we'd love to hear from you.

ed@gliadiagnostics.com
Edmond Sorich
Director & Founder
+61 450 507 237
Edmond Sorich, Director & Founder of GLIA Diagnostics