Sydney, Australia – 12 March 2025 | BlinkLab Limited (ASX:BB1) ("BlinkLab" or the "Company") is pleased to announce that the first patient has been tested in its pivotal U.S. autism diagnostic study, marking the official commencement of the largest digital diagnostic trial for autism in the United States. The trial is designed to validate BlinkLab Dx1, an AI-powered, smartphone-based diagnostic tool that aims to become a critical aid for the early assessment of autism.
Highlights
First U.S. clinical trial participant successfully tested at PriMED Clinical Research LLC in Dayton, Ohio.
The study aims to enroll 100 participants at first, expanding to approximately 750-900 children as participants for the main trial.
Final FDA 510(k) submission targeted for the end of CY2025, paving the way for market entry in the United States.
Partnership with North Shore Pediatric Therapy & PriMED Clinical Research hoping to accelerate recruitment as the study continues.
Addressing an Urgent Medical Need
The American Academy of Pediatrics (AAP) recommends autism screening at 18 and 24 months, yet many children experience significant diagnostic delays, often missing crucial early intervention windows. BlinkLab's innovative technology aims to bridge this gap, providing faster, more reliable autism assessments during a child's critical developmental stages.
Crystal Jackson, Site Manager at PriMED Clinical Research, commented: "Dr. Rogelio Amisola, Principal Investigator and PCR's team of dedicated investigators & coordinators are thrilled to be the first U.S. site to screen participants in this monumental milestone for BlinkLab. We are hopeful our quality of data will assist BlinkLab Dx in advancing their AI technology to support medical professionals in the early detection of autism—bringing innovation and hope to families everywhere!"
Dr. Henk-Jan Boele, Cofounder & CEO of BlinkLab, stated: "Launching our U.S. trial marks a very special and important moment for BlinkLab. Our mission has always been to connect fundamental neuroscience with clinical practice through accessible technology, thereby enhancing autism diagnostic evaluations and enabling early intervention for children. After extensive app and portal development, stimulus refinement, and testing in hundreds of children, we are very confident in our FDA study's potential. I truly believe that this is a transformative moment. Early diagnosis is life-changing, and BlinkLab is dedicated to empowering families and healthcare providers with AI-driven tools for accurate, accessible, and timely autism assessments."
Pathway to FDA Clearance
The results of this study will form the foundation of BlinkLab's FDA 510(k) submission, expected by CY2026. Regulatory clearance will allow BlinkLab to commercially launch in the U.S., supporting widespread clinical adoption and ensuring more children receive timely developmental assessments and interventions.
