BlinkLab Limited has delivered strong diagnostic results in its U.S. autism pilot study, exceeding FDA performance thresholds and setting the stage for a pivotal 510(k) trial. The company also expanded its clinical trial network and nears completion of its European ADHD study.
- U.S. autism pilot study achieves 83.7% sensitivity and 84.7% specificity
- FDA confirms pivotal 510(k) trial design and recruitment strategy
- Expansion to eight U.S. clinical sites including Rush University Medical Center
- European ADHD study in final recruitment stages with 332 subjects tested
- Appointment of Dr Henk-Jan Boele as Managing Director strengthens leadership
Strong Pilot Data Paves Way for Regulatory Progress
BlinkLab Limited (ASX, BB1), an Australian innovator in AI-powered neurodevelopmental diagnostics, has reported compelling results from its U.S. autism pilot study. Enrolling 485 children across diverse clinical profiles, the study demonstrated diagnostic sensitivity of 83.7% and specificity of 84.7%, comfortably surpassing the FDA’s pre-agreed thresholds of 65% for both metrics. This performance not only validates BlinkLab’s smartphone-based diagnostic platform but also de-risks the transition into the pivotal 510(k) registrational trial planned for 2026.
The pilot’s real-world design, including children with mild autism, overlapping conditions like ADHD, and undiagnosed community recruits, highlights the robustness of BlinkLab’s technology in complex diagnostic settings. This contrasts with many existing digital tools that struggle with borderline cases, positioning BlinkLab as a differentiated player in the neurodevelopmental diagnostics space.
Regulatory Alignment and Clinical Network Expansion
Formal discussions with the U.S. Food and Drug Administration have confirmed the study design, performance benchmarks, and participant recruitment strategies for the upcoming pivotal trial. BlinkLab has expanded its clinical trial network to eight leading U.S. institutions, including the recent onboarding of Rush University Medical Center. This network spans respected autism research and clinical centres, providing broad geographic and demographic coverage essential for robust trial execution.
Site activation and staff training are underway, with first patient testing targeted for the first quarter of 2026. The pivotal study aims to enrol approximately 528 children, a figure refined downward from initial estimates thanks to insights gained during the pilot, which should reduce costs and timelines without compromising statistical power.
European ADHD Study Nears Completion
Complementing its autism program, BlinkLab’s European ADHD study, conducted in partnership with Mental Care Group, is in its final recruitment phase with 332 children assessed. This study leverages the same neurometric platform and machine learning framework validated in the autism pilot, underscoring the platform’s versatility across neurodevelopmental disorders.
Given ADHD’s prevalence and the current lack of objective, scalable diagnostic tools, BlinkLab’s progress here could open significant new markets. The European dataset will underpin the development of BlinkLab Dx 2 and support regulatory and commercial strategies in Europe.
Leadership and Financial Positioning
In a strategic leadership move, Dr Henk-Jan Boele was appointed Managing Director during the quarter, reflecting the company’s shift from development to pivotal clinical execution and early commercialisation. The company also acknowledged the departure of Non-Executive Director Jane Morgan.
Financially, BlinkLab used A$1.762 million in operating activities during the quarter and held A$5.5 million in cash at period end. Post-quarter, the company received an R&D tax incentive refund of A$822,205, bolstering its cash position ahead of the pivotal trial commencement.
Looking ahead, BlinkLab is focused on executing its pivotal U.S. FDA 510(k) autism study, completing the European ADHD data analysis, maintaining regulatory alignment, and engaging early with clinicians and commercial partners to pave the way for adoption.
Bottom Line?
BlinkLab’s robust pilot data and expanded clinical network set a confident tone for its pivotal trials and future commercialisation efforts.
Questions in the middle?
- How will BlinkLab’s pivotal trial results influence FDA clearance timelines and market entry?
- What commercial partnerships or licensing deals might BlinkLab pursue post-trial?
- Can the platform’s success in autism diagnostics translate effectively to ADHD and other neurodevelopmental conditions?