22 May 2025 – Perth, Australia | BlinkLab Limited is commencing the main study phase of its pivotal US-based FDA 510(k) diagnostic trial for its smartphone-based autism diagnostic tool with the engagement of a major new clinical site. The Southwest Autism Research & Resource Center (SARRC), a nationally recognised leader in autism research and clinical services, has been selected as the first clinical site for this next phase for trialling BlinkLab’s autism diagnostic tool, BlinkLab Dx 1.
The main study will involve the recruitment of up to 900 new participants, following the pilot phase, testing up to 100 children. Testing is set to begin in the coming weeks, with data from the pilot phase currently being analysed. BlinkLab’s final submission to the US Food & Drug Administration is expected in Q1 CY2026.
Highlights:
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SARRC selected as first new clinical site for main study phase of BlinkLab Dx 1’s FDA 510(k) trial.
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Recruitment of 750 - 900 additional participants will begin after pilot phase is finalised.
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Full study enrolment target of up to 1,000 children to be tested, across up to ten clinical sites in the United States.
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Final FDA submission for the trial is anticipated Q1 CY2026 to support regulatory clearance of BlinkLab Dx 1 diagnostic tool.
Dr Christopher J. Smith, Chief Science Officer at SARRC, commented: "At SARRC we are committed to improving early detection of autism and efficient access to diagnostic evaluations for all families. To that end, we support out-of-the-box thinking about the use of technology to help expedite and make objective results easily obtainable, so more children can get into treatment sooner."
Commenting on the partnership with SARRC, Co-founder and CEO, Dr Henk-Jan Boele, stated: “We are thrilled to collaborate with the SARRC—an esteemed institution in the US with extensive experience in conducting clinical trials and efficiently recruiting children at high volumes. We feel privileged to work alongside such a capable team! I'm pleased that my team made the strategic decision to implement a pilot phase ahead of the main study. This proactive step proved invaluable in optimizing recruitment workflows and refining standard operating procedures for clinicians, ultimately laying the groundwork for a more cost-effective and labor-efficient main study."
BlinkLab’s Chairman, Mr Brian Leedman, also commented: “Shortly we will commence data analysis on the first 100 patients in the initial pilot phase of this registrational study. The rate at which BlinkLab has reached this pivotal milestone has been quicker than anticipated, primarily due to a rapid rate of recruitment alongside a demonstrated enthusiasm from participating families.”
About BlinkLab Dx 1
BlinkLab Dx 1 is a smartphone-based neurological diagnostic aid designed to assist clinicians in identifying autism in young children through an engaging video-based test and machine learning analysis of subtle behavioural responses. The tool is designed to support earlier and more accessible screening for autism, improving outcomes through early intervention.
For further information please contact:
Dr Henk-Jan Boele
Chief Executive Officer
[email protected]
Brian Leedman
Non-Executive Chairman
[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, ADHD, schizophrenia, and other neurodevelopmental conditions. 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]