16 March 2026 – Perth, Australia | BlinkLab Limited (ASX:BB1) has completed the clinical site network for its pivotal U.S. FDA 510(k) study of BlinkLab Dx 1, with the University of Arkansas joining as the tenth and final participating site.
The milestone completes the onboarding of all clinical centres for the Company’s pivotal study of its smartphone-based diagnostic aid for autism, positioning BlinkLab to begin first patient testing later this month and commence the main study phase in the first quarter of 2026.
The FDA-endorsed pivotal trial is designed to validate both the usability and diagnostic accuracy of BlinkLab Dx 1. The study is expected to enrol a minimum of 528 children aged two to 11 years across a network of leading U.S. autism clinical and academic institutions.
The addition of the University of Arkansas finalises what BlinkLab describes as one of the most comprehensive and clinically rigorous autism diagnostic study networks assembled in the digital health field. The completed site network is intended to provide a geographically and demographically diverse participant population and to support a robust study protocol ahead of regulatory submission.
This pivotal registrational study follows the completion of its U.S. Pilot Study in 485 children, where BlinkLab Dx 1 demonstrated 83.7% sensitivity and 84.7% specificity against independent gold-standard clinical diagnoses. The result also exceeded the >65% sensitivity and >65% specificity thresholds agreed with the U.S. Food and Drug Administration for the pivotal program.
The pilot study was intended to de-risk the forthcoming FDA trial and support BlinkLab’s regulatory pathway for BlinkLab Dx 1, which the Company is developing as an AI-powered diagnostic aid to assist clinicians in the assessment of autism.
Commenting on the finalisation of the clinical site network, Dr Henk-Jan Boele, Managing Director and CEO of BlinkLab, stated: “We are proud to announce the finalisation of our clinical site network for the upcoming pivotal 510(k) study. These top-tier clinical and research centres will be instrumental not only in the timely completion of our regulatory study, but also in supporting post-FDA-clearance commercialisation. Together, these key opinion leaders in the autism field will help shape the future of autism assessment and define the role that AI-enabled technologies, such as BlinkLab, will play in clinical decision-making. At BlinkLab, we are excited to begin the next phase of this journey, with participant recruitment expected to commence later this month.”
BlinkLab said the strategic importance of the completed network extends beyond regulatory clearance, with the participating institutions expected to contribute to future commercialisation, clinical workflow integration, engagement with guideline and payer stakeholders, and broader adoption following any FDA clearance.
A successful pivotal study and subsequent FDA 510(k) clearance would position BlinkLab Dx 1 as a first-of-its-kind AI-powered diagnostic aid that could be deployed at scale to support earlier and more objective autism assessments, with the aim of addressing long wait times, regional inequities, and delayed access to care and support.
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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 Dx 1, 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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