22 October 2025 – Sydney, Australia | BlinkLab Limited (ASX:BB1), an ASX-listed digital healthcare company developing AI-powered diagnostic tools, today announced the successful completion and unblinding of its U.S. Pilot Study evaluating the performance of its smartphone-based autism diagnostic test, BlinkLab Dx 1. The pilot results demonstrate strong diagnostic accuracy, while a recent meeting with the U.S. Food and Drug Administration (FDA) confirmed regulatory alignment ahead of the pivotal 510(k) trial.
The Pilot Study enrolled 485 children across a demographically diverse and clinically heterogeneous population, including participants with a broad spectrum of neurodevelopmental profiles such as autism spectrum disorder (ASD), ADHD, speech delays, and learning disorders. Results showed that BlinkLab Dx 1 achieved 83.7% sensitivity and 84.7% specificity compared to gold-standard clinical assessments. These outcomes significantly exceed the FDA’s minimum benchmark of >65% for both sensitivity and specificity, paving the way for progression to the next phase of regulatory testing.
The study population was drawn from leading U.S. diagnostic centres, including PriMED Clinical Research and NorthShore Pediatric Therapy, and included a mix of children undergoing or having recently completed neurodevelopmental assessments, as well as community samples. This population was selected to closely replicate real-world clinical conditions where diagnostic uncertainty is often high.
Unlike earlier studies with more controlled participant groups, this Pilot Study was designed as a stringent “real-world” test of BlinkLab’s technology. The Dx 1 device maintained high performance despite clinical complexity, validating its ability to handle subtler or borderline cases of autism that often challenge traditional assessment tools.
Following the unblinding of the Pilot Study data on 17 October 2025, BlinkLab met with the FDA, which endorsed several key updates to the trial protocol for the upcoming Pivotal 510(k) Study. These include a revised sample size of 528 participants (reduced from 1,000), drawn from a blend of specialised autism centres and broader community sources. The updated study design is expected to reduce cost and streamline timelines without compromising statistical integrity.
BlinkLab also identified novel digital biomarkers during its Pilot Study analysis. These include features associated with restricted and repetitive behaviours (RRBs), intended for integration into the Dx 1 model before the pivotal trial. These enhancements are expected to further improve diagnostic accuracy and clinical interpretability.
BlinkLab Chairman, Brian Leedman, commented:
“We are thrilled with these results as they validate the strength of our approach and the tremendous progress our team has made. Building a model that can interpret behavior through a smartphone and achieve this level of accuracy in this study population is an extraordinary accomplishment. The learnings from the pilot give us the confidence that our pivotal study is likely to deliver the results needed for FDA clearance. Ultimately, our technology which utilizes neuroscience, AI, and smartphone-tech, will help millions of families access earlier, faster, and more objective diagnosis. We are also encouraged by the FDA’s feedback and look forward to commencing the main 510(k) study in partnership with the many prestigious centers of neurological research in North America.”
BlinkLab Co-Founder and CEO, Dr. Henk-Jan Boele, added:
“I would like to express my deepest gratitude to all the families who participated in our study, to the dedicated clinicians at PriMED and NorthShore, to our supportive investors, and to the incredible BlinkLab team for their commitment and collaboration throughout this journey. Patient recruitment efforts were met with overwhelming interest, surpassing the original goal of 100 children and resulting in 485 participants, nearly matching the number needed for BlinkLab’s upcoming FDA 510(k) study. Looking ahead, we are excited to continue our mission to transform mental health diagnostics through accessible, objective, and scalable digital tools. This Pilot Study marks just the beginning of a new era in how neuroscience and technology come together to improve patient care.”
BlinkLab’s 510(k) study will be conducted across leading academic and clinical institutions in the United States, including Cincinnati Children’s Hospital, Seattle Children’s Hospital, University of Pennsylvania, MU Thompson Center for Autism & Neurodevelopmental Disorders, Southwest Autism Research & Resource Center, University of Nebraska Medical Center, and the Vanderbilt Kennedy Center.
BlinkLab remains on track to submit its FDA 510(k) clearance application in 2026.
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 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]