BlinkLab (ASX:BB1) has announced the commencement of the main study phase of its pivotal US-based FDA 510(k) diagnostic trial for its smartphone-based autism diagnostic tool, with the engagement of a significant new clinical site.
BlinkLab Dx 1 is a smartphone-based neurological diagnostic aid designed to assist clinicians in identifying autism in young children through an engaging video-based test and machine learning analysis of subtle behavioural responses. The tool is designed to support earlier and more accessible screening for autism, improving outcomes through early intervention.
The Southwest Autism Research and Resource Center (SARRC), a nationally recognised leader in autism research and clinical services, has been selected as the first clinical site for this next phase of trialling BlinkLab Dx 1.
The main study will recruit up to 900 new participants, following the pilot phase, which will test up to 100 children. Testing is set to begin in the coming weeks, with data from the pilot phase currently being analysed. BlinkLab said its final submission to the US FDA is expected in the first quarter of the calendar year 2026.
BlinkLab co-founder and CEO Dr Henk-Jan Boele said, “We are thrilled to collaborate with the SARRC—an esteemed institution in the US with extensive experience in conducting clinical trials and efficiently recruiting children at high volumes. We feel privileged to work alongside such a capable team! I'm pleased that my team made the strategic decision to implement a pilot phase ahead of the main study. This proactive step proved invaluable in optimising recruitment workflows and refining standard operating procedures for clinicians, ultimately laying the groundwork for a more cost-effective and labour-efficient main study."
BlinkLab’s chairman, Brian Leedman, added, “Shortly, we will commence data analysis on the first 100 patients in the initial pilot phase of this registrational study. The rate at which BlinkLab has reached this pivotal milestone has been quicker than anticipated, primarily due to a rapid rate of recruitment alongside a demonstrated enthusiasm from participating families.”
