Highlights:
- Eighth Leading Sites Onboarded: Rush University Medical Center (“Rush”) joins BlinkLab’s pivotal FDA 510(k) clinical trial for its smartphone-based autism diagnostic aid, BlinkLab Dx 1, expanding the U.S. site network to eight premier autism centers.
- Backed by Strong US Pilot Data: The onboarding of Rush follows the completion of BlinkLab’s 485 children U.S. Pilot Study, where Dx 1 achieved 83.7% sensitivity and 84.7% specificity, significantly exceeding the FDA’s agreed pivotal study performance benchmark of >65% / >65%.
- Pivotal Study to Commence Shortly: The FDA-endorsed pivotal 510(k) trial will enroll approximately 528 children across a network of leading academic and clinical institutions and is expected to have its first subject tested in Q1 CY2026.
- Strategic Network of Top Centers: Rush is joining Cincinnati Children’s, Seattle Children’s, University of Pennsylvania, MU Thompson Center, SARRC, University of Nebraska Medical Center, and Vanderbilt Kennedy Center, representing many of the most respected autism institutions in the U.S.
- Positioned for Breakthrough Commercialisation: Engagement with key opinion leaders (KOLs) and future commercial partners is now commencing in parallel with the pivotal trial, supporting U.S. market access planning for a scalable, AI-powered autism diagnostic solution.
BlinkLab Limited (ASX:BB1) (“BlinkLab”, or the “Company”), a leader in AI-powered digital diagnostics, is pleased to announce that Rush University Medical Center, one of the Midwest’s foremost autism centers and a member of the Autism Care Network, has joined the Company’s pivotal U.S. clinical study of BlinkLab Dx 1. Rush becomes the eighth premier institution to participate in BlinkLab’s FDA 510(k) registrational trial, further strengthening what is emerging as one of the most comprehensive and clinically rigorous autism diagnostic studies conducted in the digital health field.
This milestone follows BlinkLab’s recently completed U.S. Pilot Study of 485 children, in which BlinkLab Dx 1 demonstrated 83.7% sensitivity and 84.7% specificity versus independent gold-standard clinical diagnoses, performance that significantly exceeds the >65% sensitivity and >65% specificity threshold agreed with the U.S. Food and Drug Administration (FDA) for the pivotal study1. These results confirm both the robustness of the technology in real-world clinical populations and the Company’s readiness to progress its pivotal 510(k) program.
About Rush University Medical Center
Rush is widely recognized for its multidisciplinary autism services, integrating expert clinicians, evidence-based assessment, and comprehensive family support. As part of the Autism Care Network, Rush contributes to improving standards of care for tens of thousands of children and families annually. Rush’s participation will provide high-quality, demographically diverse data and deepen the study’s reach into real-world clinical settings, an essential component of BlinkLab’s strategy to build a scalable diagnostic solution usable far beyond specialist centers.
Pivotal 510(k) Study and Strategic Importance
The pivotal study will enroll approximately 528 children aged 2–11 years across eight leading U.S. sites:
- Cincinnati Children’s Hospital2
- Seattle Children’s Hospital3
- University of Pennsylvania4
- MU Thompson Center for Autism & Neurodevelopmental Disorders5
- Southwest Autism Research & Resource Center6
- University of Nebraska Medical Center7
- Vanderbilt Kennedy Center8
- Rush University Medical Center
1 ASX Announcement (22 October 2025) – “Pilot Study Confirms High Diagnostic Accuracy & Readiness”
2 ASX Announcement (26 August 2025) – “Two additional strategic partnerships with top ranked U.S. institutions advance BlinkLab’s FDA submission”
3 ASX Announcement (26 August 2025) – “Two additional strategic partnerships with top ranked U.S. institutions advance BlinkLab’s FDA submission”
4 ASX Announcement (21 August 2025) – “ASX Announcement (26 August 2025) – “Two additional strategic partnerships with top ranked U.S. institutions advance BlinkLab’s FDA submission”
5 ASX Announcement (17 September 2025) – “BlinkLab Engages The University of Missouri’s Thompson Center for Autism & Neurodevelopment as its sixth Clinical Site for FDA 510(k) Diagnostic Trial”
6 ASX Announcement (22 May 2025) – “BlinkLab Expands U.S. Clinical Trial Network: University of Nebraska Medical Center Engaged as Second Site in Main Phase of FDA 510(k) Study”
7 ASX Announcement (8 July 2025) – “BlinkLab Expands U.S. Clinical Trial Network: University of Nebraska Medical Center Engaged as Second Site in Main Phase of FDA 510(k) Study”
8 ASX Announcement (18 September 2025) – “BlinkLab Onboards ‘The Vanderbilt Kennedy Center’ as Seventh Clinical Site for FDA 510(k) Autism Trial”
Together, these sites represent a geographically diverse and demographically representative sample of the U.S. population, each with a proven track record in autism research and clinical trial execution.
By anchoring its pivotal trial in this elite network, BlinkLab is not only generating high-quality evidence for regulatory clearance but also building deep relationships with key opinion leaders (KOLs) and future implementation partners within major U.S. centers of excellence. These collaborations are expected to play a critical role in:
- Informing real-world clinical workflows for Dx 1
- Supporting guideline and payer engagement
- Accelerating adoption upon FDA clearance
Dr Henk-Jan Boele, Co-founder and CEO of BlinkLab, commented:
“We’re at a meaningful stage for BlinkLab. With eight world-leading U.S. autism centers now engaged, strong pilot results, and our pivotal trial about to begin, we’re moving from discovery research into real-world application.
It can seem repetitive as we bring new sites on board, but each one matters. Every collaboration is an achievement and a clear signal that leading clinicians and institutions want to work with us on early and more accurate autism diagnosis. That’s something we should take real confidence in.
Our focus now is on working closely with clinicians, many of which are KOLs in the autism field, to prepare for implementation. Our goal hasn’t changed since we started: to deliver a scalable, accessible diagnostic tool that makes early autism detection possible for every family, everywhere. Step by step.”
A successful pivotal study and subsequent FDA 510(k) clearance would position BlinkLab Dx 1 as a first-of-its-kind, AI-powered diagnostic aid that can be deployed at scale bringing earlier, more objective autism assessments into clinics and communities and helping address long waitlists, regional inequities, and delayed care and support.
This announcement has been approved by the Board of Directors
