12 February 2026 – Sydney, Australia | BlinkLab Limited (ASX:BB1), a leader in AI-powered digital diagnostics, has expanded its U.S. clinical footprint with the onboarding of Drexel University as the ninth site in its pivotal FDA 510(k) trial for BlinkLab Dx 1, the Company’s Software as a Medical Device (SaMD) autism diagnostic aid.
The addition of Drexel University strengthens what is emerging as one of the most comprehensive and clinically rigorous digital autism diagnostic studies conducted to date, ahead of anticipated study commencement in Q1 2026.
The FDA-endorsed pivotal study will enrol approximately 528 children aged 2–11 years across a geographically and demographically diverse network of leading U.S. institutions. Drexel joins an established group of elite centres, including Cincinnati Children’s Hospital, Seattle Children’s Hospital, the University of Pennsylvania, MU Thompson Center for Autism & Neurodevelopmental Disorders, Southwest Autism Research & Resource Center, University of Nebraska Medical Center, Vanderbilt Kennedy Center and Rush University Medical Center.
Strong U.S. Pilot Data De-Risks Pivotal Study
Drexel’s onboarding follows the successful completion of BlinkLab’s U.S. Pilot Study involving 485 children, announced in October 2025. In that study, BlinkLab Dx 1 demonstrated:
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83.7% sensitivity
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84.7% specificity
These results significantly exceeded the >65% sensitivity and >65% specificity performance thresholds agreed with the U.S. Food and Drug Administration (FDA) for progression into the pivotal 510(k) study.
The Pilot Study results confirmed both the robustness of the Company’s AI-powered smartphone-based diagnostic technology in real-world clinical populations and its readiness to advance into the registrational phase.
Commenting on Drexel’s participation, Dr Henk-Jan Boele, Co-founder and CEO of BlinkLab, stated:
“I am very pleased to see an institution with such a longstanding track record of leadership in autism and neurodevelopmental research join BlinkLab for its FDA 510(k) diagnostic program. The University has enormous expertise across its research programs and specific autism initiatives will make it a valuable partner for this pivotal stage of our own clinical work.
Institutions of this calibre are critical to giving our study the best chance at achieving the level of rigour required to demonstrate our technology at work, as well as maintaining the highest scientific and clinical standards for the sake of both our research output and our participants. I am grateful that Drexel University wants to work with BlinkLab. Having Drexel University as part of our pivotal trial will reinforce the momentum that we are now building with a strong start to 2026.”
Strategic Importance of Elite Clinical Network
The pivotal 510(k) trial is designed not only to support regulatory clearance, but also to anchor BlinkLab within a network of leading U.S. autism research and clinical institutions.
Collectively, the nine 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.
Beyond regulatory evidence generation, these collaborations are expected to play a critical role in:
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Informing real-world clinical workflows for Dx 1
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Supporting guideline and payer engagement
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Accelerating adoption upon FDA clearance
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 capable of being deployed at scale to deliver earlier, more objective autism assessments. The technology aims to address long waitlists, regional inequities, and delayed access to care and support across the U.S. healthcare system.
About Drexel University and the A.J. Drexel Autism Institute
Drexel University is a private, research-intensive institution based in Philadelphia, Pennsylvania. Through the A.J. Drexel Autism Institute, the University plays a nationally recognised role in population-level autism surveillance, diagnostic access and evidence-based policy development.
The Institute publishes the National Autism Indicators Report (NAIR) series, one of the most widely referenced datasets informing how autism is identified, diagnosed and supported across U.S. healthcare and education systems.
Drexel’s participation in the pivotal trial adds clinical and scientific credibility, as well as strategic relevance to how new diagnostic tools may be evaluated and integrated into broader U.S. autism screening and care pathways over time.
About us:
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 and ADHD. Our most advanced product is an autism diagnostic aid for clinicians that leverages the power of smartphones, AI and machine learning, that enables early and accurate detection of autism enabling early intervention during crucial early windows of brain development. 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.
Contact details:
Ollie Hannon
Account Director
Jane Morgan Management
[email protected]
