Key Highlights

  • BlinkLab’s European ADHD study achieved 82% sensitivity and 83% specificity in children aged 6 to 17 years using smartphone-based digital neurobehavioural biomarkers.
  • The results support development of BlinkLab Dx2, an AI model designed to expand the company’s diagnostic platform beyond autism to ADHD assessment.
  • The multicentre study was completed through collaboration with Mental Care Group in Europe without direct study costs to BlinkLab.
  • The company plans further regulatory preparation, including potential US clinical studies aligned with its existing development pathway.

BlinkLab (ASX:BB1) has announced positive findings from its European case-control study evaluating smartphone-based digital neurobehavioural biomarkers for attention-deficit/hyperactivity disorder (ADHD) assessment. The study represents a key development milestone as the company expands its artificial intelligence-driven diagnostic platform beyond autism and explores applications in a broader neurodevelopmental healthcare market.

The study assessed children aged 6 to 17 years, comparing participants with clinically confirmed ADHD diagnoses against a control group without ADHD or other neurodevelopmental conditions. Results from the research provide early evidence supporting the potential application of BlinkLab’s technology in identifying ADHD-related behavioural markers through smartphone-based assessments.

European ADHD Study Demonstrates Diagnostic Potential

The study collected neurometric data from participants recruited through multiple Mental Care Group (MCG) centres in the Netherlands and community-based recruitment channels. Children completed short smartphone assessments designed to capture digital neurobehavioural biomarkers, including involuntary responses such as blinking patterns and facial reflexes.

Following participant screening and exclusions, the final analysed dataset included 208 children. Of these, 117 participants had confirmed ADHD diagnoses, while 91 formed the comparison group.

BlinkLab’s machine learning Dx2 algorithm achieved sensitivity of 82%, meaning it correctly identified children with ADHD in the study cohort at that rate. The model also achieved specificity of 83%, indicating its ability to correctly classify participants without ADHD.

The company stated that the dataset represents one of the larger case-control cohorts reported for ADHD assessment tools and provides an important foundation for further validation activities.

Development of BlinkLab Dx2 AI Model

The study findings are being used to support development of BlinkLab Dx2, a new artificial intelligence model intended to detect ADHD alongside the company’s existing autism-focused technology.

BlinkLab’s platform uses smartphone-based assessments to collect objective digital biomarkers that may complement existing clinical evaluation methods. Current ADHD diagnosis typically involves interviews, behavioural observations, questionnaires and assessments from families, schools and healthcare professionals.

The company believes digital biomarkers could provide additional quantitative information during diagnostic workflows. The technology is being developed as a potential clinical support tool rather than a replacement for professional medical judgement.

Expanding Healthcare Applications Through Digital Biomarkers

ADHD represents a significant area of interest within neurodevelopmental healthcare due to the complexity of assessment pathways and demand for accessible diagnostic solutions. Traditional evaluation processes can require substantial clinical resources and may involve extended waiting periods for patients and families.

BlinkLab’s smartphone-based approach aims to provide scalable data collection through widely available consumer technology. Beyond diagnosis, the company is also investigating whether its biomarkers could support measurement of symptom characteristics, monitoring of treatment responses and applications in pharmaceutical research.

The ability to measure behavioural features objectively could create additional opportunities in clinical development programs where consistent assessment tools are required.

Regulatory Pathway and Future Development Strategy

BlinkLab plans to use the European study results as a foundation for further development of Dx2. The company intends to prepare for a regulatory study program in the United States, following a similar framework established for its autism diagnostic product, BlinkLab Dx1.

Future activities are expected to include pilot studies with clinical centres and potential prospective regulatory studies, subject to regulatory engagement and successful completion of development milestones.

The company also plans to evaluate regulatory and commercialisation opportunities in other regions, including Europe under the Medical Device Regulation framework.

Collaborative Research Model Supports Platform Expansion

The ADHD study was completed in collaboration with Mental Care Group, which provided clinical expertise, participant access and diagnostic review support. BlinkLab managed smartphone assessment procedures and neurometric data collection while retaining ownership of study data and intellectual property generated through the collaboration.

The partnership model demonstrates a capital-efficient approach to clinical research by combining healthcare expertise with BlinkLab’s technology platform.

Conclusion

BlinkLab’s European ADHD study provides important validation data for the company’s efforts to extend its AI-based diagnostic platform beyond autism applications. The results demonstrate that smartphone-derived digital biomarkers can identify measurable differences associated with ADHD within the study population. Further clinical validation, regulatory studies and technology development will determine the future role of BlinkLab Dx2 in healthcare assessment pathways.