BlinkLab Posts 84% Accuracy in Autism Pilot, Expands US Clinical Sites
BlinkLab has completed its U.S. autism pilot study with strong diagnostic accuracy and expanded its pivotal FDA trial to seven leading research centers, positioning itself for regulatory submission in late 2026.
- Pilot phase data collection completed with high diagnostic accuracy
- Expanded pivotal FDA 510(k) trial to seven top U.S. autism centers
- Clinical trial agreements executed; site activation and training set for early 2026
- European ADHD trial progressing on schedule with 300 participants targeted
- Strong cash position of A$7.2 million supports ongoing clinical and regulatory work
Pilot Study Completion Marks Key Progress
BlinkLab Limited (ASX, BB1), a digital healthcare innovator focused on AI-powered diagnostics for neurodevelopmental disorders, has reached a significant milestone by completing data collection for its U.S. autism pilot study. The company is now preparing for data unblinding, a critical step ahead of its pivotal FDA 510(k) clinical trial phase. The pilot results, announced shortly after the quarter ended, demonstrated a sensitivity of 83.7% and specificity of 84.7% in diagnosing autism among 485 children, surpassing the regulatory threshold of 65% and approaching the upper limits of current clinical diagnostic accuracy.
Strategic Expansion of Pivotal Trial Network
During the quarter, BlinkLab significantly broadened its pivotal trial footprint by onboarding six prestigious U.S. autism research centers, including Cincinnati Children’s Hospital, Seattle Children’s Research Institute, and the University of Pennsylvania’s Perelman School of Medicine. These additions join the Southwest Autism Research & Resource Center, creating a robust network that enhances the scientific rigor and credibility of the upcoming pivotal study. Executing clinical trial agreements and finalizing budgets with these sites sets the stage for site activation and clinical staff training scheduled for early 2026.
European ADHD Trial Advances on Track
Parallel to its autism program, BlinkLab’s European ADHD diagnostic trial continues to progress steadily. Coordinated by the Mental Care Group in The Netherlands, recruitment across five active sites is on schedule to yield data from approximately 300 participants by the end of 2025. This dataset will support the development of BlinkLab’s ADHD diagnostic platform, complementing its autism diagnostic tool and expanding the company’s footprint in neurodevelopmental diagnostics.
Financial Health Supports Regulatory Ambitions
Financially, BlinkLab maintains a solid cash balance of A$7.232 million as of September 30, 2025, following quarterly operating cash outflows primarily driven by research and development activities. This capital position is sufficient to fund the pivotal FDA 510(k) study and initiate subsequent diagnostic development phases. The company continues to align its software and data management systems with FDA regulatory standards, including cybersecurity and human-factor validation, to de-risk the path toward submission targeted for the second half of 2026.
Looking Ahead
With site activation and clinical training planned for early 2026, BlinkLab is poised to commence its pivotal trial under a unified and efficient operational framework. The company’s dual focus on autism and ADHD diagnostics positions it well to address significant unmet needs in early neurodevelopmental disorder detection. Investors will be watching closely as BlinkLab moves toward its FDA submission milestone and continues to build momentum in both U.S. and European markets.
Bottom Line?
BlinkLab’s near-term execution on pivotal trials and regulatory submissions will be critical to translating promising pilot data into commercial success.
Questions in the middle?
- How quickly will BlinkLab begin recruiting participants for the pivotal FDA 510(k) autism trial?
- What are the potential regulatory hurdles remaining before FDA clearance can be achieved?
- How will BlinkLab’s dual autism and ADHD diagnostic platforms impact its market positioning and revenue prospects?
