BlinkLab ADHD study delivers strong results and opens pathway beyond autism

BlinkLab Ltd (ASX:BB1, OTC:BKLBF, FRA:P41) has reported positive results from a European ADHD study, marking a major step toward expanding its smartphone-based diagnostic platform beyond autism.

The study achieved sensitivity of 82% and specificity of 83% in children aged six to 17, supporting further development of BlinkLab Dx2, an artificial intelligence model designed to identify digital neurobehavioural markers associated with attention-deficit/hyperactivity disorder.

BlinkLab will now begin preparations for a US regulatory study program, following a similar development strategy to that established for its autism-focused BlinkLab Dx1 product. 

Large ADHD dataset supports Dx2 development

The multicentre study recruited 375 children through Mental Care Group centres in the Netherlands and from the broader community.

After excluding participants with co-occurring neurodevelopmental or psychiatric conditions, as well as those taking medication, BlinkLab analysed data from 208 children.

Of these, 117 had a confirmed clinical diagnosis of ADHD and 91 had no ADHD diagnosis or other neurodevelopmental condition.

BlinkLab’s machine-learning algorithm correctly identified 82% of children in the ADHD group and correctly classified 83% of the control group.

The company said the cohort represented one of the largest case-control datasets reported for ADHD assessment tools.

Participants completed brief smartphone-based assessments that measured digital neurobehavioural biomarkers, including subtle and involuntary responses such as blinking and facial reflexes.

The resulting objective neurometric markers were also positively associated with clinical observations contained in participants’ diagnostic reports.

Regulatory studies planned in the US

The study was exploratory and was not designed to support a regulatory submission.

BlinkLab said further prospective clinical validation, model development and regulatory clearance would be required before Dx2 could be used as an ADHD diagnostic aid.

The company plans to initiate a US pilot study with leading ADHD clinical centres, followed by a prospective US Food and Drug Administration registrational study, subject to regulatory engagement and successful completion of the pilot.

BlinkLab expects to use its existing clinical and regulatory framework, including relationships with contract research organisations and regulatory advisers involved in the development of BlinkLab Dx1.

It will also assess regulatory and commercial opportunities in Europe under the EU Medical Device Regulation.

Managing director and CEO Dr Henk-Jan Boele said the results gave the company confidence in the technology and its decision to progress Dx2 toward regulatory studies.

“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,” he said.

Capital-efficient European collaboration

The study was completed in collaboration with Mental Care Group at no cost to BlinkLab.

BlinkLab conducted the smartphone assessments and analysed the neurometric data, while Mental Care Group provided clinical expertise, participant access and multidisciplinary diagnostic review.

BlinkLab retains ownership of the study data and all intellectual property generated through the collaboration.

The company believes smartphone-based measurements could complement clinical judgement, improve workflow efficiency and help reduce the long waiting periods commonly associated with ADHD assessment.

Beyond paediatric diagnosis, BlinkLab intends to investigate whether its biomarkers can support ADHD assessment in adults, monitor symptom progression and treatment response, and provide objective measures for pharmaceutical clinical trials.

About BlinkLab

BlinkLab was founded by neuroscientists at Princeton University and is developing smartphone-based diagnostic technology using artificial intelligence, machine learning and objective reflex measurements.

Its lead product, BlinkLab Dx1, is being developed as an autism diagnostic aid for clinicians, while Dx2 is intended to broaden the platform’s capabilities to include ADHD.