BlinkLab’s Autism Diagnostic Pilot Exceeds Targets as FDA Trial Preparations Advance

Blinklab Limited ( (AU:BB1) ) has issued an announcement.

BlinkLab reported strong results from its U.S. autism pilot study, in which its BlinkLab Dx 1 diagnostic achieved 83.7% sensitivity and 84.7% specificity across 485 children in a clinically diverse, real-world population, comfortably above performance thresholds discussed with U.S. regulators and reducing risk ahead of a pivotal 510(k) trial. The company has secured regulatory alignment with the FDA on trial design and benchmarks, expanded its U.S. study network to eight sites in preparation for first patient testing in early 2026, advanced a European ADHD study toward completion, made a leadership change with the appointment of co-founder Dr Henk-Jan Boele as managing director, and received an R&D tax refund, all of which strengthen its clinical, regulatory and financial footing as it moves toward large-scale trials and early commercialisation.

More about Blinklab Limited

BlinkLab Limited is an Australian digital health company focused on developing AI-powered digital diagnostics for neurodevelopmental conditions, with an initial emphasis on tools for autism and ADHD. Its core product, BlinkLab Dx 1, is designed to be used in real-world clinical settings to improve diagnostic accuracy and scalability, particularly in the U.S. and European healthcare markets.

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Current Market Cap: A$115.8M

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