BlinkLab (ASX:BB1) has reached a critical regulatory milestone with the onboarding of the University of Arkansas as its tenth and final clinical site.
The addition completes the infrastructure required for the company's pivotal FDA 510(k) clinical trial of BlinkLab Dx 1, a pioneering smartphone-based diagnostic aid designed for the early detection of autism.
The inclusion of such a prestigious academic institution strengthens the geographical and demographic diversity of the participant pool, ensuring a robust framework for what is poised to be one of the most comprehensive digital health studies in the field.
The upcoming pivotal trial, scheduled to commence in Q1 2026, follows a successful US pilot study involving 485 children.
That pilot demonstrated a sensitivity of 83.7% and a specificity of 84.7%, significantly outperforming the FDA's performance benchmarks of 65%.
With the clinical network now fully established, BlinkLab expects to enrol a minimum of 528 children across its ten elite sites to validate the usability and diagnostic accuracy of the AI-powered platform.
The completion of this network de-risks the path toward potential FDA clearance.
Patient testing is expected to begin later this month, marking the final stage in the company's quest to provide a scalable, accessible tool for neurodevelopmental assessment.
At the time of reporting, BlinkLab's share price was $0.82.