BlinkLab Reports Positive ADHD Assessment Results from European Dx2 Diagnostic Platform Study

BlinkLab (ASX: BB1) has reported positive results from a European study of its Dx2 AI-driven, smartphone-based diagnostic tool to detect digital neurobehavioural biomarkers in young children with and without attention deficit hyperactivity disorder (ADHD).

The study collected neurometric data from an initial 375 children aged between six and 17 years recruited across multiple Mental Care Group (MCG) centres in the Netherlands.

Children from the general community were also included to form a “neurotypical” control group for comparison.

Those with (co-occurring) neurodevelopmental or psychiatric conditions and those taking medication were excluded in order to establish a clearly defined ADHD group and a clean comparison group.

That left 208 children for the study, of which 117 (or 56%) had a confirmed ADHD diagnosis and 91 (or 44%) had no neurodevelopmental conditions.

Collecting Diagnostic Biomarkers

Participants completed brief smartphone-based assessments to collect the biomarkers that make up BlinkLab’s diagnostic platform.

This included the detection of often-subtle and involuntary behaviours such as blinking or facial reflexes.

BlinkLab’s machine learning Dx2 algorithm correctly identified 82% of children in the ADHD group as exhibiting the target neurobehavioural features associated with ADHD (sensitivity) and correctly classified 83% of children in the comparison group (specificity).

Importantly, the smartphone-derived objective neurometric markers were positively associated with subjective clinical observations documented in participant diagnostic reports.

Enhancing Assessment Pathways

The study results provide the first evidence that digital neurobehavioural biomarkers can detect differences associated with ADHD.

The findings are an important first step in evaluating how BlinkLab’s platform could enhance ADHD assessment pathways and extend Dx2’s detection capabilities beyond the autism-focused Dx1 platform to include ADHD.

It could potentially be used alongside traditional ADHD assessment, which relies on clinical interviews, behavioural observations, questionnaires, and input from families and schools, but can be is highly subjective and resource-intensive.

Digital smartphone-based measures have the potential to complement clinical judgement, improve workflow efficiency in clinical settings, and help families access appropriate care sooner.

Unmet Medical Need

“Achieving 82% sensitivity and 83% specificity is the first major step in developing Dx2 as an improved model to detect ADHD, […] which represents a significant unmet medical need—and, in our view, a substantially larger addressable market than paediatric autism,” managing director Dr Henk-Jan Boele said.

“There is no blood test or brain scan for ADHD; diagnosis is a subjective clinical judgement and […] every objective test is therefore graded against a benchmark that carries its own error.”

“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."

“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,” Mental Care Group chief executive officer Jan Willem van der Windt added.

“We thank BlinkLab for making their platform and scientific expertise available to us, and the children, parents, and colleagues who made this study possible.”