About GLIA Diagnostics
GLIA Diagnostics (GLIA) is an Australian medical technology company developing an investigational point-of-care (PoC) platform for the objective, rapid assessment of traumatic brain injury and concussion.
GLIA Diagnostics was founded in 2015 and is headquartered in Mosman, Sydney, New South Wales, Australia. The company was established to address a critical unmet clinical need: the absence of objective, rapid, point-of-care diagnostics for traumatic brain injury (TBI) and concussion.
TBI is one of the most common and costly neurological conditions globally. Mild TBI — commonly called concussion — accounts for the vast majority of cases, yet it remains a clinical diagnosis based on subjective symptom reporting, neurocognitive testing, and neuroimaging that is almost always normal in mild injury. There is no approved blood test for concussion in routine clinical use in Australia.
GLIA's investigational platform is designed to provide an objective biological signal — a quantitative microRNA biomarker result — that complements existing assessment tools and supports clinical decision-making at the point of need, without requiring laboratory infrastructure.
GLIA NeuroTESTA is an investigational diagnostic device that analyses a panel of seven brain-enriched microRNA (miRNA) biomarkers from a finger-stick blood sample. The assay is designed to deliver a quantitative result in approximately 20 minutes at the point of care — at the sports sideline, military field base, emergency department, or remote clinical setting — without laboratory infrastructure.
GLIA NeuroTESTA is an investigational device. It is not approved or cleared by any regulatory authority for clinical diagnosis.
Device Specifications
MicroRNAs are short, non-coding RNA molecules (approximately 22 nucleotides) that regulate gene expression post-transcriptionally. Brain-enriched microRNAs are highly expressed in neurons and glial cells. Following TBI, disruption of the blood-brain barrier releases these miRNAs into the bloodstream, where they circulate in a stable, cell-free form bound to proteins or encapsulated in exosomes.
Their tissue-specific expression pattern makes brain-enriched miRNAs a direct molecular signal of neuronal damage. Unlike protein biomarkers such as GFAP and UCH-L1, which are also released from damaged brain tissue, miRNAs offer a large panel of distinct molecular targets, enabling a multi-marker approach that may improve sensitivity and specificity across injury severities.
GLIA's investigational 7-marker panel was identified through iterative human studies, selecting miRNAs that demonstrate consistent differential expression in TBI subjects compared to controls across multiple cohorts and injury contexts.
GLIA's miRNA panel is supported by five human studies and cohorts, generating four peer-reviewed publications. All publications are authored by Mitra B et al. and published in the Journal of Clinical Neuroscience.
2017
Mitra B et al. (2017). Pilot study investigating circulating microRNA biomarkers in sport-related concussion. Journal of Clinical Neuroscience.
First human study establishing the diagnostic signal of brain-enriched miRNAs in sport-related concussion.
2022
Mitra B et al. (2022). Validation cohort: microRNA panel performance in mild TBI across sport and civilian populations. Journal of Clinical Neuroscience.
Validation of the miRNA panel across a broader mild TBI cohort spanning sport and civilian injury contexts.
2023
Mitra B et al. (2023). Military cohort: miRNA biomarkers in blast-related TBI. Journal of Clinical Neuroscience.
Extension of the panel to blast-induced TBI in a military population — a distinct injury mechanism from sport concussion.
2024
Mitra B et al. (2024). Extended cohort: 7-marker panel sensitivity and specificity across the TBI severity spectrum. Journal of Clinical Neuroscience.
Largest cohort to date; characterises panel performance across mild, moderate, and severe TBI.
GLIA's platform is designed for deployment across four primary contexts where objective, rapid TBI assessment is currently unavailable or inadequate.
Professional and high-performance athletes require objective, rapid concussion assessment to support safe return-to-play decisions. Current tools — symptom checklists and neurocognitive tests — are subjective and vulnerable to under-reporting. GLIA's platform is designed to provide an objective biological anchor at the sideline or in the team medical room.
Community and amateur athletes sustain the majority of sport-related concussions but have the least access to objective diagnostics. GLIA's point-of-care design — no laboratory, no specialist — is intended to extend objective assessment to every level of sport, including junior and regional competitions.
Blast overpressure is a leading cause of TBI in military personnel. Conventional assessment tools are poorly suited to austere environments and cannot detect the diffuse axonal injury characteristic of blast TBI. GLIA's platform is designed for field deployment, enabling objective assessment from the front line to the field hospital.
Emergency departments, neurology clinics, and rehabilitation services manage large volumes of TBI presentations. An objective, rapid biomarker result could support triage, imaging decisions, discharge planning, and monitoring — complementing existing clinical assessment without requiring specialist interpretation.
Chief Executive Officer
Biomedical commercialisation background. Responsible for strategy, partnerships, investor relations, and regulatory pathway. Stakeholder network spans elite sport, defence, clinical research, and medtech investment.
Clinical Science Advisor
Emergency physician and TBI researcher. Lead author on all four peer-reviewed publications underpinning GLIA's miRNA panel. Extensive experience in clinical TBI research across sport, military, and civilian populations.
Clinical Advisor
Neurosurgeon with extensive TBI clinical and research expertise. Provides clinical guidance on device application, study design, and neurosurgical context.
IP Advisor
Intellectual property strategy for the miRNA panel, assay methodology, and device. Ensures GLIA's core technology is protected across key jurisdictions.
Commercialisation Advisor
Market access and commercialisation strategy. Advises on go-to-market pathways, partnership structures, and commercial development across sport, defence, and clinical channels.
Manufacturing Advisor
Medical device manufacturing and supply chain. Advises on scale-up, manufacturing quality systems, and supply chain strategy for the NeuroTESTA device.
GLIA NeuroTESTA is pursuing regulatory clearance as a Class IIb in vitro diagnostic medical device under the Australian Therapeutic Goods Administration (TGA) framework. The company is also monitoring pathways under the US FDA De Novo and 510(k) processes and the European IVDR. All current activities are conducted under investigational use provisions.
GLIA NeuroTESTA is an investigational device. It is not approved or cleared by any regulatory authority (including the TGA, FDA, or CE) for clinical diagnosis. All content on this site is for informational and research purposes only.
Clinical collaborators, research partners, investors, and defence organisations are welcome to get in touch.
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