BlinkLab (ASX:BB1) has announced the addition of the Thompson Center for Autism and Neurodevelopment at the University of Missouri as the sixth US clinical site for its pivotal FDA 510(k) diagnostic trial.
The Thompson Center is a nationally recognised leader in autism care, research, education, and policy. Its expertise in neurodevelopmental conditions and specialised diagnostic services makes it a powerful partner as BlinkLab advances its AI-powered diagnostic platform, BlinkLab Dx 1, designed to detect autism spectrum disorder (ASD) via smartphone-based testing.
The pivotal study, now moving from its pilot to main phase, will evaluate BlinkLab Dx 1 by comparing AI-derived digital biomarkers, including reflexive behaviours such as blinking and micro-expressions, with traditional clinician-led diagnostic methods. The trial will include at least 260 autistic and 260 neurotypical children, with total enrolment potentially reaching up to 900 participants.
The engagement of the Thompson Center bolsters BlinkLab’s clinical network, enhancing recruitment capacity and ensuring a more diverse, high-quality dataset for regulatory submission.
BlinkLab said it remains on track to complete its FDA study in the second quarter of calendar year 2026, with final submission expected in the third quarter of that year.
By combining computer vision, AI, and smartphone accessibility, BlinkLab aims to revolutionise the early detection of autism, bringing scalable, affordable, and clinically validated tools into the hands of families and clinicians worldwide.