30 June 2025 – Perth, Australia | BlinkLab Limited (ASX:BB1), a digital health company developing AI-powered smartphone-based diagnostic technology for autism and ADHD, is pleased to announce that it has received Institutional Review Board (IRB) ethics approval from the WIRB-Copernicus Group (WCG) for commencing the main phase of its United States FDA 510(k) clinical trial for its flagship autism diagnostic tool ("BlinkLab Dx 1"). The IRB approval marks a major regulatory milestone in BlinkLab's strategy to bring accessible, scalable autism screening to the global healthcare market.
Highlights:
IRB ethics approval has been granted to initiate the main phase of BlinkLab's FDA 510(k) trial in the United States.
The multi-centre clinical trial is to be conducted across several U.S. autism centres, targeting up to a total of 1,000 child participants.
The pilot phase of the clinical trial is now nearing completion, with results expected in Q3 of CY2025, following physician evaluations.
The IRB approval now enables the onboarding of new clinical sites for the main study phase and recruitment of further trial participants.
Both the study design and strategy for data analysis were previously given positive feedback through FDA pre-submission meetings.
Dr Henk-Jan Boele, BlinkLab's Cofounder and CEO, commented: "The fact that our trial is classified as minimally invasive and exempt from most IDE regulatory requirements significantly streamlines our path forward. This IRB approval is a huge milestone that reflects our commitment to conducting rigorous, responsible research as we advance our mission to deliver accessible, AI-driven diagnostic tools for autism and beyond. I'd like to thank the entire team for their hard work and long hours in securing all necessary regulatory approvals to initiate the main phase of our US study."
The IRB approval from the WCG (a leading provider of clinical oversight based in Princeton, New Jersey) for the main study phase follows the successful completion of the pilot phase (involving 100 participants) earlier this year, as well as positive feedback from the U.S. FDA on BlinkLab's clinical design and data strategy in late-2024. With this approval secured, BlinkLab will now commence onboarding additional trial sites and begin participant recruitment across multiple U.S. autism centres.
About the FDA 510(k) Diagnostic Trial
The clinical trial is aimed at evaluating BlinkLab's AI-powered smartphone app, which uses visual and auditory stimuli to measure involuntary facial responses such as blinking, facial expressions and head movements in the participant (which typically occur differently in people with autism to reactions from neurotypical people).
The study will compare BlinkLab's app-based assessments against traditional autism diagnostics to assess its accuracy and validate the app's performance in a clinical setting. The trial is structured as a double-blinded, within-subjects comparison study.
A minimum of 260 children diagnosed with autism and 260 neurotypical children will be enrolled, with the total cohort expected to scale up to 1,000 participants depending on site recruitment rates.
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.
