Perth, Australia – 17 September 2025 | BlinkLab Limited (ASX:BB1), a digital health company developing smartphone-based diagnostic tools for neurodevelopmental conditions, has today announced a further expansion of its U.S. clinical trial site network with the engagement of the Thompson Center for Autism & Neurodevelopment at the University of Missouri. The Center will assist in running BlinkLab’s pivotal FDA 510(k) trial that seeks to evaluate its AI-powered diagnostic platform, BlinkLab Dx 1, for the detection of autism spectrum disorder (ASD).
This marks the sixth U.S. clinical site engaged for the trial and strengthens BlinkLab’s efforts to collect a diverse, high-quality dataset that supports its regulatory submission pathway.
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Specialised Autism Center: The Thompson Center joins as the sixth clinical research site for the main study phase of BlinkLab’s pivotal U.S. FDA 510(k) diagnostic trial.
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Leading Neurodevelopmental Expertise: The Thompson Center is widely recognised for its leadership in autism care, research, education, and even public policy in the U.S. Midwest.
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Main Study Launch Approaching: The FDA trial’s pilot phase is nearing completion, with the main study phase to follow shortly after.
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Regulatory Timeline on Track: BlinkLab expects the 510(k) study to be completed in Q2 of CY2026, with final submission to the U.S. Food and Drug Administration (FDA) in Q3 of CY2026 .
A part of the University of Missouri, the Thompson Center for Autism & Neurodevelopment is a leading U.S. institution that offers a range of comprehensive services for individuals and families affected by autism and other neurodevelopmental conditions. The Center integrates world-class clinical care, educational programs, research, and advocacy efforts towards policy. The Center’s specialised diagnostic and evaluation services, combined with a focus on innovation in research, make it an ideal partner for BlinkLab’s mission to enhance early autism detection with its diagnostic tool.
The BlinkLab Dx 1 platform is designed to assist with the diagnosis of autism using AI and computer vision on its smartphone app. The double-blind U.S.-based study aims to compare BlinkLab’s digital biomarkers (derived from reflexive behaviours such as blinking and micro-expressions in the face) with results from traditional diagnostic methods based on clinicians’ observations. The study will have at least 260 autistic and 260 neurotypical children as participants, with total enrolment potentially reaching up to approximately 900 participants. BlinkLab is expanding its clinical network to optimise recruitment and ensure data quality and diversity.,
Jane Morgan
Jane MOrgan Management
Investor & Media Relations
[email protected]
About us:
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 to deliver screening tests specifically designed for children as young as 18 months old. 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.
Contact details:
Jane Morgan
Jane Morgan Management
Investor & Media Relations
[email protected]