- BlinkLab Limited has reported 82% sensitivity and 83% specificity in a European study of its smartphone-based ADHD assessment technology, representing the first evidence supporting expansion of its diagnostic platform beyond autism.
- The study assessed 208 children aged six to 17, capturing involuntary behaviours such as blinking and facial reflexes via smartphone, with the algorithm correctly identifying children with and without ADHD at comparable rates to clinical assessment.
- The technology, known as BlinkLab Dx2, aims to add objective digital measurements to existing ADHD diagnostic processes rather than replace clinical judgement, potentially reducing delays and improving workflow efficiency for clinicians.
- ADHD's higher prevalence makes it a larger addressable clinical opportunity than paediatric autism; however, further prospective validation, model refinement, and regulatory clearance are required before the technology can be used as a diagnostic aid.
- BlinkLab plans to initiate a US pilot study with ADHD clinical centres and, subject to successful completion, progress to a US Food and Drug Administration registrational study, whilst also exploring regulatory and commercialisation pathways in Europe.
5 August 2026 – Perth, WA | BlinkLab Limited (ASX: BB1) has reported 82% sensitivity and 83% specificity in a European study of its smartphone-based ADHD assessment technology, providing the first evidence to support expanding its diagnostic platform beyond autism.
The results mark an early development milestone for BlinkLab Dx2, an artificial intelligence model designed to identify digital neurobehavioural markers associated with attention-deficit/hyperactivity disorder in children.
The study assessed children aged six to 17 through brief smartphone-based tests that captured subtle, involuntary behaviours, including blinking and facial reflexes. These objective measurements were compared with diagnoses established through multidisciplinary clinical review.
Of the 375 children initially recruited, 208 met the study’s criteria and were included in the analysis. This comprised 117 children with a confirmed ADHD diagnosis and 91 children without ADHD or another neurodevelopmental condition.
BlinkLab’s machine-learning algorithm correctly identified 82% of children in the ADHD group, a measure known as sensitivity, and correctly classified 83% of the comparison group, known as specificity. The company said the cohort represented one of the largest case-control datasets reported for ADHD assessment tools.
The findings are significant because ADHD assessments generally rely on interviews, behavioural observations, questionnaires and input from families and schools. BlinkLab is seeking to add objective digital measurements to that process, rather than replace clinical judgement.
The company said smartphone-based assessments could potentially help clinicians manage resource-intensive diagnostic pathways, improve workflow efficiency and reduce delays for children and families seeking assessment.
The study also broadens the potential application of BlinkLab’s technology beyond its core autism program. BlinkLab said ADHD’s higher prevalence made it a larger addressable clinical opportunity than paediatric autism, although the technology remains at an early stage of development.
The results were positively associated with clinical observations recorded in participants’ diagnostic reports, supporting the potential clinical relevance of the smartphone-derived markers. However, the exploratory study was not designed to support a regulatory submission.
Further prospective clinical validation, refinement of the Dx2 model and regulatory clearance will be required before the technology could be used as an ADHD diagnostic aid.
The multicentre study was completed with European mental healthcare provider Mental Care Group at no cost to BlinkLab. Mental Care Group provided access to participants, clinical expertise and diagnostic reviews, while BlinkLab conducted the smartphone assessments and analysed the neurometric data.
BlinkLab retains ownership of the study data and the intellectual property generated through the collaboration, supporting a capital-efficient pathway for developing Dx2.
BlinkLab Managing Director and Chief Executive Officer Dr Henk-Jan Boele stated:
“Achieving 82% sensitivity and 83% specificity is an exciting result and the first major step in developing BlinkLab Dx2, our improved model designed to detect ADHD in addition to autism. ADHD represents a significant unmet medical need and, in our view, a substantially larger addressable market than paediatric autism.
These numbers deserve context. There is no blood test or brain scan for ADHD. Diagnosis is a subjective clinical judgement, and two experienced clinicians assessing the same child often disagree. Every objective test is therefore graded against a benchmark that carries its own error. Seen that way, BlinkLab's 82% sensitivity and 83% specificity sit close to the practical ceiling for any test scored against subjective clinical opinion. And that ceiling is precisely the opportunity we intend to break through, by measuring biology directly instead of chasing an imperfect label.
Our new ADHD results give us confidence in the technology and in our decision to progress towards a regulatory study program for Dx2, following the same FDA regulatory pathway and development strategy we established for our autism product.
I am incredibly proud of our team for what we anticipate will be the first smartphone-based digital biomarker test for ADHD in the world. I am grateful for the opportunity to work with Mental Care Group and with the children and families whose participation made this study possible.
Beyond diagnosis, we believe we are at the forefront of developing quantitative digital biomarkers capable of measuring ADHD symptom domains (hyperactivity, inattentiveness and impulsivity) and severity and, potentially, tracking treatment response.
This matters precisely because it moves us past the subjectivity of the label: if we can measure the underlying neurobiology directly, we are no longer bound by the reliability of clinical opinion. Such biomarkers could support clinicians in optimising diagnosis and personalising therapy, and provide pharmaceutical companies with objective endpoints for clinical trials in children and potentially adults”
Mental Care Group Chief Executive Officer Jan Willem van der Windt commented:
“As one of the largest providers of youth mental health care in Europe, we see every day what long waiting times and resource-intensive assessment pathways mean for children and their families.
These BlinkLab results show that a brief smartphone measurement could help our clinicians direct extensive diagnostics to the children who need them most. We eagerly look forward to implementing BlinkLab into our diagnostic workflow.
Technology will not replace professional judgement, but it can support it. We thank BlinkLab for making their platform and scientific expertise available to us, and the children, parents and colleagues who made this study possible.”
BlinkLab will now use the European findings to continue developing Dx2 and plans to initiate a US pilot study with ADHD clinical centres.
Subject to regulatory engagement and successful completion of that pilot, the company plans to progress to a prospective US Food and Drug Administration registrational study. BlinkLab also intends to assess regulatory and commercialisation pathways in other jurisdictions, including Europe under the EU Medical Device Regulation.
About us:
About BlinkLab Limited
About BlinkLab Limited BlinkLab Limited was founded by neuroscientists at Princeton University and is developing a smartphone-based diagnostic platform for autism. Its most advanced product, BlinkLab Dx1, is an autism diagnostic aid for clinicians that leverages smartphones, artificial intelligence and machine learning to capture objective, reflex-based measures, supporting earlier and more accurate autism identification. This enables timely intervention during critical periods of brain development. BlinkLab is led by an experienced management team and Board with deep expertise in digital healthcare, computer vision and AI, supported by a Scientific Advisory Board of leading experts in autism and brain development.
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Jane Morgan Management
Investor & Media Relations
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