BlinkLab Ltd (ASX:BB1) Commences U.S. Autism Diagnostic Study
13 March 2025
Price Sensitive Announcement $
Highlights:
● BlinkLab’s first patient has now been tested at PriMED Clinical Research LLC,
officially launching the U.S. clinical trial.
● The study aims to validate BlinkLab Dx 1 as a critical diagnostic aid for clinicians
in early assessment of developmental disorders.
● Together with North Shore Pediatric Therapy, PriMED will participate in the initial 100-participant study, with data expected to be released in Q3 2025. Following this phase, the clinical trial will proceed to the main study, aiming to enroll an additional 750-900 children.
● Final FDA 510(k) submission is expected at the end of CY2025.
Overview:
BlinkLab Limited, a leading digital healthcare innovator, announced the successful completion of the first patient tested in its pivotal U.S. autism diagnostic study. The initial testing took place at PriMED Clinical Research LLC (“PriMED”) in Dayton, Ohio, officially marking the commencement of the largest digital diagnostic trial for autism in the United States.
The study’s primary objective is to validate the BlinkLab Dx1 test as a diagnostic aid for clinicians. The AI-powered, smartphone-based neurological assessment is designed to provide parents and practitioners with a rapid and accurate tool to support the early detection of developmental conditions like autism, helping to improve long-term outcomes.
PriMED Clinical Research, a PriMED Physicians research company, was the first1 of two2clinical sites announced that have been selected for the initial 100-patient phase of the study, with further patient enrolments for the main study expected to ramp up in the coming weeks.
Pathway to Regulatory Clearance
The results of this pivotal study will form the foundation of BlinkLab’s submission for FDA 510(k) clearance, which is anticipated in CY2026. This regulatory milestone is expected to pave the way for the Company’s market entry in the United States and help to bridge the current diagnostic gap that currently exists for identifying developmental conditions like autism. BlinkLab’s technology aims to provide families with accessible, efficient diagnostic solutions during the critical developmental windows for early intervention.
Company Notes:
Crystal Jackson, Certified Clinical Research Coordinator and Site Manager for PriMED Clinical Research, stated: “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 and CEO of BlinkLab, commented: “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.”
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