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BlinkLab Limited (ASX:BB1) (“BlinkLab”, or the “Company”), a leader in AI-powered digital diagnostics, is pleased to announce that Drexel University (“Drexel” or the “University”), a globally recognised research university and innovator in neurodevelopmental research, has joined as a clinical site for the Company’s pivotal U.S. regulatory trial for BlinkLab Dx 1.
This makes Drexel University the ninth institution to participate in the FDA 510(k) registrational trial across the United States, helping to ensure a comprehensive and clinically rigorous study, along with a geographically and demographically diverse participant population of children as part of evaluating the diagnostic capabilities of BlinkLab’s technology. The growing network of clinical sites continues to strengthen the study’s design, and what is emerging as one of the most comprehensive and clinically rigorous autism diagnostic studies conducted in the digital health field.
Commenting on the enrollment, 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.
About Drexel University and the A.J. Drexel Autism Institute
Drexel University is a private research-intensive institution located in Philadelphia, Pennsylvania, USA. As a university, Drexel is widely recognised for its academic excellence and the real-world impact of its research output and translational research efforts, especially across the health sciences, public health, and neurodevelopmental research including autism and ADHD. Drexel University, through its A.J Drexel Autism Institute, plays a unique and influential role within the U.S. autism ecosystem that extends beyond traditional academic research. The Institute is nationally recognised for its leadership in population- level autism surveillance, diagnostic access, and evidence-based policy development, working closely with government agencies, healthcare systems and community organisations across the United States.
Notably, the Institute is the publisher of the National Autism Indicators Report (NAIR) series, one of the most widely referenced datasets informing how autism is identified, diagnosed and supported across the U.S. healthcare and education systems. These reports are routinely used by policymakers, public health authorities and clinical leaders to shape national and state-level autism programs.
As a result, Drexel’s involvement in BlinkLab’s pivotal FDA study brings not only clinical and scientific credibility, but also strategic relevance to how new diagnostic tools may be evaluated, adopted and integrated into broader U.S. autism screening and care pathways over time.
