BlinkLab's ADHD data opens a second path beyond autism

ADHD Results Create a Second Regulatory Opportunity

BlinkLab Limited (ASX:BB1) has produced its first quantitative signal that its smartphone-based neurometric platform may extend beyond autism, reporting 82% sensitivity and 83% specificity in an exploratory ADHD study involving 208 children in the Netherlands. The study included 117 children with a confirmed ADHD diagnosis and 91 neurotypical controls aged six to 17.

The results came from the company's European ADHD study, which had completed recruitment earlier in the year. BlinkLab said its leading inattention biomarker was positively correlated with clinical observations, but the study was a case-control exercise and was not designed to support a regulatory submission. Prospective validation and FDA or European clearance would still be required before Dx2 could be used as an ADHD diagnostic aid.

Dx2 US Pilot Targeted for 2027

BlinkLab has begun preparing a US pre-FDA pilot study for Dx2, expected to start in the second quarter of calendar 2027 and finish in the second half of that year. Subject to regulatory engagement and a successful pilot, the company expects a pivotal study and FDA submission in calendar 2028.

The proposed program would use much of the infrastructure already assembled for Dx1, including the company's CRO relationship, regulatory advisers, quality management system and clinical network. BlinkLab says the same 10 to 15-minute smartphone assessment could eventually support measures of ADHD symptom domains, severity and treatment response, although those potential applications remain investigational.

Autism Trial Keeps the Near-Term Regulatory Focus

Dx1 remains the nearer-term catalyst. BlinkLab's prospective, multicentre, double-blinded FDA 510(k) pivotal study continued during the quarter, with completion expected in Q4 CY2026, results submission targeted for Q1 CY2027 and an FDA response targeted for Q2 CY2027. The study's timeline is unchanged despite the University of Pennsylvania and University of Arkansas leaving the program; Indiana University School of Medicine replaced both sites and indicated it could recruit more participants than the departing centres combined.

The FDA previously agreed to a pivotal-study performance threshold above 65% sensitivity and specificity. That bar compares with 84% sensitivity and 85% specificity in BlinkLab's earlier Dx1 US pilot, but the pivotal study remains the evidence base required for any clearance decision. The company has also appointed Dr Raphael Bernier, a former Apple Health Clinical Lead for Mental Health and former executive director of Seattle Children's Autism Center, to its Board as it prepares for potential US commercialisation.

Cash Supports a Dense Clinical Milestone Calendar

BlinkLab held A$16.2 million in cash at 30 September and used A$1.802 million in net operating cash during the quarter. Research and development, clinical study support and platform work accounted for A$1.330 million of expenditure, while administration and corporate costs were A$500,000. On the quarter's reported operating cash use, the Appendix 4C indicated approximately nine quarters of funding, although that is a mechanical runway estimate rather than a guarantee of future spending or financing needs.

Four exploratory programs are expected to produce readouts in Q4 CY2026, covering adult autism assessment, adult autism and lifestyle monitoring, early dementia detection and ketamine treatment monitoring. BlinkLab is also progressing Morocco's government-funded nationwide autism screening program, which formally launched on 22 October after the Morocco screening program was announced earlier this year. None of these exploratory programs is currently intended to support a regulatory submission.