Perth, Australia – 18 September 2025 | BlinkLab Limited (ASX:BB1), a leading digital health company developing AI-powered smartphone-based diagnostic tools, has today announced that it has engaged The Vanderbilt Kennedy Center in Nashville, Tennessee as its seventh U.S. clinical research site for its ongoing pivotal FDA 510(k) diagnostic trial aimed at autism.
Seventh U.S. clinical site engaged: The Vanderbilt Kennedy Center joins BlinkLab's U.S. trial location network for its FDA 510(k) registration trial.
Pivotal trial advancing to main study phase: The initial pilot phase is nearing completion, and the main trial will begin soon to assess BlinkLab Dx 1's diagnostic accuracy across a large and diverse participant population.
FDA submission: Trial completion is expected in Q2 of CY2026, with final FDA submission targeted for Q3 of CY2026.
Multisite design ensures generalisability: The inclusion of what are now seven leading institutions across the U.S. will support robust data collection, enhancing the reliability and applicability of results.
The onboarding of the Vanderbilt Kennedy Center (a nationally recognised Centre of Excellence for Developmental Disabilities) further strengthens BlinkLab's trial network as it transitions from the initial pilot study to the main study phase.
BlinkLab Co-founder and CEO, Dr Henk-Jan Boele, stated: "We are very pleased to welcome The Vanderbilt Kennedy Center as another Tier 1 partner in our FDA 510(k) trial. With seven onboarded sites up till now, we are moving at pace with onboarding clinical sites and finalising Clinical Trial Agreements (CTAs). At BlinkLab, we are encouraged by the high level of motivation from each center to begin enrolling participants. We maintain momentum as we will be transitioning soon from the pilot into the main FDA study phase. This keeps us firmly on schedule for our planned submission to the FDA in 2026."
About the Vanderbilt Kennedy Center
Founded in 1965 and a part of the Vanderbilt University Medical Center, the Vanderbilt Kennedy Center is one of the original U.S. Intellectual and Developmental Disabilities Research Centers. In 2005, it was designated a Center of Excellence for Developmental Disabilities, and it is focused on conducting advanced research, offering clinical and community services, and providing training for families and a range of professionals. It houses the Treatment and Research Institute for Autism Spectrum Disorders (TRIAD), and advocates for evidence-based interventions, early diagnoses, and policy change aimed at meaningful change for people with autism and other neurodevelopmental conditions.
About the BlinkLab Dx 1 FDA Trial
The ongoing FDA trial is evaluating BlinkLab Dx 1, which is the Company's smartphone-based autism diagnostic tool that leverages AI and computer vision to detect reflexive behaviours primarily in the face – such as blinking, facial expressions, and micro-movements. The double-blind study will compare digital biomarkers captured through the BlinkLab Dx 1 app with traditional clinical diagnosis approaches.
The study will enrol a minimum of 260 children with autism and 260 neurotypical control participants, with total participation potentially reaching 900 children across all clinical sites.
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About BlinkLab Limited (ASX:BB1)
BlinkLab Limited, a Company founded by neuroscientists at Princeton University, over the past several years has fully developed a smartphone based diagnostic platform for autism and ADHD. Our most advanced product is an autism diagnostic test that leverages the power of smartphones, AI and machine learning. This marks a significant advancement, considering traditional diagnoses typically occur around five years of age, often missing the crucial early window for effective intervention. BlinkLab is led by an experienced management team and directors with a proven track record in building companies and vast knowledge in digital healthcare, computer vision, AI and machine learning. Our Scientific Advisory Board consists of leading experts in the field of autism and brain development allowing us to bridge most advanced technological innovations with groundbreaking scientific research.
