BlinkLab Limited (ASX:BB1), a leader in AI-powered digital diagnostics, today announced that Rush University Medical Center (“Rush”) has joined the Company’s pivotal U.S. clinical study for BlinkLab Dx 1, its smartphone-based diagnostic aid for autism. Rush becomes the eighth leading institution to participate in the FDA-endorsed 510(k) trial, expanding what is set to become one of the most comprehensive digital health autism studies conducted in the United States.
Major U.S. Autism Center Added to Pivotal Study
Rush, one of the Midwest’s foremost autism centres and a member of the Autism Care Network, brings multidisciplinary expertise and access to a large and diverse patient population. Its participation enhances the depth and geographical reach of BlinkLab’s pivotal study and adds significant clinical robustness to the trial network.
This onboarding follows BlinkLab’s recently completed U.S. Pilot Study involving 485 children, in which BlinkLab Dx 1 demonstrated 83.7% sensitivity and 84.7% specificity, significantly outperforming the FDA-agreed pivotal study benchmark of >65% for both measures. These results support the Company’s readiness to advance into late-stage regulatory validation.
Eight Premier U.S. Autism Centres Now Engaged
The pivotal study will enrol approximately 528 children aged 2–11 years across eight leading U.S. academic and clinical institutions:
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Cincinnati Children’s Hospital
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Seattle Children’s Hospital
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University of Pennsylvania
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MU Thompson Center for Autism & Neurodevelopmental Disorders
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Southwest Autism Research & Resource Center (SARRC)
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University of Nebraska Medical Center
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Vanderbilt Kennedy Center
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Rush University Medical Center
Together, these organisations represent many of the most respected autism centres in the U.S., providing high-quality, demographically diverse data and enabling rigorous evaluation in real-world clinical environments.
Building Strategic Foundations for Commercialisation
By anchoring its pivotal trial within this elite network, BlinkLab is accelerating engagement with clinicians, key opinion leaders (KOLs), and prospective commercial partners. These relationships are expected to support:
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Optimisation of real-world clinical workflows for BlinkLab Dx 1
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Guideline development and payer engagement
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Market access planning and adoption pathways upon FDA clearance
Dr Henk-Jan Boele, Co-founder and CEO of BlinkLab, said:
“We’re at a meaningful stage for BlinkLab. With eight world-leading U.S. autism centers now engaged, strong pilot results, and our pivotal trial about to begin, we’re moving from discovery research into real-world application.
It can seem repetitive as we bring new sites on board, but each one matters. Every collaboration is an achievement and a clear signal that leading clinicians and institutions want to work with us on early and more accurate autism diagnosis. That’s something we should take real confidence in.
Our focus now is on working closely with clinicians, many of which are KOLs in the autism field, to prepare for implementation. Our goal hasn’t changed since we started: to deliver a scalable, accessible diagnostic tool that makes early autism detection possible for every family, everywhere. Step by step.”
Positioning for a First-of-Its-Kind Diagnostic Solution
A successful pivotal study and FDA 510(k) clearance would position BlinkLab Dx 1 as a scalable, AI-powered diagnostic aid capable of transforming early autism assessment. The tool is designed to help address long waitlists, regional inequities, and delays in diagnosis by enabling clinicians to conduct earlier, more objective evaluations.
This announcement has been approved by the Board of Directors.
For further information, please contact:
Dr. Henk-Jan Boele — Chief Executive Officer
[email protected] | M: +31 (0) 611 132 247
Brian Leedman — Non-Executive Chairman
[email protected] | M: +61 (0) 412 281 780
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 aid for clinicians that leverages the power of smartphones, AI and machine learning, that enables early and accurate detection of autism enabling early intervention during crucial early windows of brain development. 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 Realtions
[email protected]
