BlinkLab’s FDA Autism Trial Faces High Stakes with New Site Addition
BlinkLab has expanded its pivotal FDA 510(k) autism diagnostic trial to nine top U.S. sites, adding Drexel University ahead of the Q1 2026 study start. This move follows a successful pilot study that exceeded FDA benchmarks, positioning BlinkLab Dx 1 for regulatory clearance.
- Drexel University joins BlinkLab’s FDA 510(k) pivotal autism diagnostic trial
- Trial network now includes nine leading U.S. clinical and academic sites
- Pilot study showed 83.7% sensitivity and 84.7% specificity, surpassing FDA thresholds
- Pivotal trial to enrol approximately 528 children aged 2–11 years
- Strategic partnerships aim to accelerate adoption post-FDA clearance
Expanding the Trial Network
BlinkLab Limited (ASX – BB1), a frontrunner in AI-powered digital diagnostics, has announced the addition of Drexel University to its pivotal FDA 510(k) clinical trial network for its autism diagnostic aid, BlinkLab Dx 1. This marks the ninth U.S. site to join the study, reinforcing the trial’s geographic and demographic diversity ahead of its expected commencement in the first quarter of 2026.
Drexel University, renowned for its neurodevelopmental research and leadership through the A.J. Drexel Autism Institute, brings significant scientific and strategic value to the trial. Its involvement not only enhances the clinical rigour but also aligns with BlinkLab’s goal of integrating new diagnostic tools into broader autism care pathways across the United States.
Strong Pilot Data Underpinning Confidence
The expansion follows a robust U.S. pilot study involving 485 children, where BlinkLab Dx 1 demonstrated sensitivity and specificity rates of 83.7% and 84.7% respectively. These results substantially exceed the FDA’s agreed minimum performance benchmarks of 65% for both metrics, providing a strong foundation for the pivotal trial.
Such performance highlights the potential of BlinkLab’s smartphone-based AI technology to deliver earlier and more objective autism assessments, addressing long-standing challenges like delayed diagnosis and regional disparities in care access.
Strategic Importance of the Clinical Network
The pivotal study will enrol approximately 528 children aged 2 to 11 across nine elite U.S. sites, including Cincinnati Children’s Hospital, Seattle Children’s Hospital, University of Pennsylvania, and now Drexel University among others. This network represents a broad and representative sample of the U.S. population, ensuring the study’s findings will be robust and generalisable.
Beyond regulatory approval, these partnerships are expected to facilitate real-world clinical adoption by informing workflows, supporting payer engagement, and accelerating integration into healthcare systems. BlinkLab’s CEO, Dr Henk-Jan Boele, emphasised the importance of such collaborations in maintaining high scientific standards and building momentum for the company’s technology.
Looking Ahead
With the pivotal trial poised to begin shortly, BlinkLab is positioning itself at the forefront of digital health innovation in autism diagnostics. Successful FDA clearance would mark a significant milestone, enabling scalable deployment of an AI-powered diagnostic aid that could transform early autism detection and intervention.
As the trial progresses, the involvement of leading institutions like Drexel University will be critical in shaping the future landscape of autism care, potentially influencing policy and clinical guidelines nationwide.
Bottom Line?
BlinkLab’s expanded trial network and strong pilot data set the stage for a pivotal moment in AI-driven autism diagnostics.
Questions in the middle?
- How quickly will the pivotal trial enrol its target of 528 children across diverse sites?
- What interim data might BlinkLab release during the trial to signal progress or challenges?
- How will Drexel University’s policy influence accelerate adoption post-FDA clearance?
