• First participant enrolled in FDA 510(k) pivotal validation
• Study led by CRO partner IQVIA-MCRA
• Builds on successful pilot study with high diagnostic accuracy
• Clear path toward FDA submission by year-end 2026

BlinkLab Limited (ASX:BB1) has announced the commencement of its validation program supporting 510(k) submission, with the first child participant now enrolled and having completed initial testing using BlinkLab Dx1. The validation program is expected to generate the pivotal core clinical and usability evidence required to support BlinkLab's planned FDA 510(k) submission. The study begins with a dedicated usability phase to ensure clinicians and caregivers can safely and effectively use the BlinkLab platform in real-world settings. This will seamlessly transition into the clinical validation phase, which is designed to evaluate diagnostic performance against established standard-of-care assessments for autism. Participant recruitment for the validation program is expected to take approximately 8 months, and BlinkLab is on track to complete these activities and submit its regulatory package to the U.S. Food and Drug Administration by the end of 2026. The registrational trial for BlinkLab Dx1 is using a double-blinded, multi-center, within-subjects comparison study design, taking place across a network of 10 leading U.S. clinical sites.

No high-importance, price-sensitive forward-looking financial metrics provided.

BlinkLab is well positioned to transform how autism is assessed in clinical practice, with a clear pathway toward FDA submission and strong execution underway.