BlinkLab Expands U.S. Clinical Trial Network with Top-Ranked Pediatric Institutions Ahead of FDA Submission

Jane Morgan Management

Perth, Australia – 26 August 2025 – BlinkLab Limited (ASX:BB1), a digital health company developing AI-powered smartphone-based diagnostic tools for neurodevelopmental conditions, today announced the expansion of its U.S. clinical trial network with the addition of two globally renowned institutions: Cincinnati Children’s Medical Center and Seattle Children’s Research Institute.

Both centres will participate in BlinkLab’s pivotal FDA 510(k) Autism Diagnostic Trial of BlinkLab Dx 1, bringing the total number of active U.S. clinical sites to five. The trial is designed to evaluate the Company’s smartphone-based diagnostic platform for early autism detection.

Key Highlights

• Two world-leading hospitals join trial: Cincinnati Children’s and Seattle Children’s are ranked among the top 10 pediatric hospitals in the U.S. and are internationally recognised for their leadership in autism research.
  
  

• Expanded U.S. trial network: BlinkLab now has five U.S. trial sites engaged, enabling broader geographic and demographic reach to support up to 900 participants.
  
  

• FDA 510(k) submission timeline: Trial completion is expected in Q2 CY2026, with a final submission to the U.S. Food and Drug Administration (FDA) targeted for Q3 CY2026.
  
  

• Strategic market alignment: The involvement of top-tier U.S. institutions bolsters clinical credibility and supports future adoption across healthcare systems.
  
  

Strategic Importance and Market Opportunity

The new partnerships are pivotal to enhancing recruitment diversity and credibility in BlinkLab’s FDA submission. The Company’s flagship product, BlinkLab Dx 1, is a smartphone-based platform using AI and machine learning to detect behavioural patterns linked to autism in children as young as 18 months, a major advancement over traditional methods that typically result in diagnoses around five years of age.

The trial is designed as a double-blind study, enrolling at least 260 autistic and 260 neurotypical children, with the potential to expand to 900 participants across the U.S.

Autism represents one of the fastest-growing areas of unmet clinical need, with current diagnostic systems limited by long wait times and subjective clinical observations. BlinkLab’s technology aims to deliver accessible, scalable, and objective diagnostics, dramatically improving early intervention access.

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.

Jane Morgan
Jane Morgan Management
Investor & Media Relations
[email protected]