Perth, Australia – 1 April 2025 | BlinkLab Limited (ASX: BB1) ("BlinkLab" or the "Company") is pleased to announce it has successfully recruited 54 children as participants, surpassing the halfway point of the initial 100-patient phase of its pivotal U.S. clinical trial to validate the Company's AI-powered smartphone-based autism diagnostic tool.
The trial is part of a regulatory pathway for FDA 510(k) clearance and has been designed to demonstrate the accuracy, accessibility, and scalability of the BlinkLab Dx 1 product as a diagnostic aid in identifying autism and other developmental conditions in children.
Highlights
54 children are now recruited in the program, exceeding the midpoint of the 100-patient initial study cohort.
Faster-than-expected recruitment highlights the scalability and convenience of BlinkLab's digital platform.
Additional research and clinical sites expected to join as the trial progresses to its main study phase.
Study completion for the initial cohort now expected by early Q3 2025.
Final FDA 510(k) submission on track for Q1 2026.
Clinical Progress Currently Ahead of Schedule
The study's initial phase, which began testing its first patient in March of 2025, is progressing ahead of schedule. Participating sites include PriMED Clinical Research LLC and North Shore Pediatric Therapy, announced earlier in the year, with the first patient tested on 12 March 2025.
Following the initial 100-participant phase, the trial will expand to include 750–900 children in the main study cohort, supporting a robust and diverse data set for regulatory approval and clinical validation.
Study Design
The ongoing study is a prospective, multicentre, double-blinded, within-subject comparison trial aimed at validating BlinkLab Dx 1 for clinical use in assisting with the diagnosis of autism. The digital diagnostic tool is designed to provide rapid, accessible, and reliable autism assessments through a smartphone interface, which hopes to address the growing demand for early, scalable screening solutions in paediatric healthcare.
Dr Henk-Jan Boele, Co-founder and CEO of BlinkLab, commented:
"We are thrilled with the rapid pace of recruitment for this pivotal registrational study. Yet again, it demonstrates the scalability and accessibility of digital diagnostic tools, and especially those that utilise common household technologies, such as the smartphones we use every day. Our technology is proving its ability to deliver fast, reliable assessments for conditions like autism, bringing us closer to enhancing the formal autism diagnosis process, as well as making it more accessible. With this momentum, we remain well on-track for study completion and our subsequent FDA 510(k) submission early next year."
Brian Leedman, Chairman of BlinkLab, added:
"Clinical research – and especially studies that require the participation of children – often face challenges with recruitment, due to the understandably sensitive nature of the research itself, parental considerations, and paediatric healthcare as a whole. In their most significant form, such challenges can lead to cost blow-outs, limitations on the data, and even discontinuation of the study. This is why we are pleased to see that recruitment for our ongoing registrational study is progressing at a pace that has quickly exceeded our initial trial milestones. This accomplishment is a culmination of the talented researchers at BlinkLab and our collaboration partners at PriMED and North Shore. The enthusiasm of participating families underscores the unmet medical need for early autism diagnosis and intervention."
