BlinkLab’s FDA Study to Enroll 1,000 Children, Targets 2026 Approval

FDA Registrational Study Underway

BlinkLab Limited (ASX:BB1), a digital healthcare innovator leveraging AI and machine learning for neurodevelopmental diagnostics, has officially commenced its FDA registrational study for BlinkLab Dx 1, its smartphone-based autism diagnostic app. The study will enroll up to 1,000 children aged 2 to 11 across multiple US clinical sites, following an initial pilot phase involving 100 participants. This phased approach aims to ensure robust data quality and diagnostic accuracy ahead of the anticipated FDA 510(k) clearance.

The company has secured Institutional Review Board (IRB) approval, with the study classified as minimal risk, streamlining participant recruitment and regulatory oversight. Four clinical sites are active, with six more to be onboarded, ensuring a demographically diverse cohort to validate the AI algorithm's performance across varied populations.

Positive Regulatory Engagement

In a strategic move to de-risk the regulatory pathway, BlinkLab held a pre-submission meeting with the US FDA, receiving encouraging feedback on its study design, endpoints, and data requirements. This early engagement confirms the appropriateness of the 510(k) clearance route and highlights the FDA's focus on algorithm validation, dataset diversity, and real-world performance metrics for AI-driven diagnostics. Such proactive collaboration is expected to expedite the review process and enhance transparency.

Strong Preliminary Study Outcomes

Supporting confidence in the registrational trial, BlinkLab recently announced final results from a pivotal autism study involving 441 participants. The study demonstrated a class-leading sensitivity of 91% and specificity of 85%, surpassing older machine learning models and competitive products. These results underpin BlinkLab's belief that Dx 1 will meet or exceed FDA accuracy requirements, positioning it as a potential breakthrough in early autism detection.

Expanding Research Collaborations

Beyond the US trial, BlinkLab is advancing its research footprint through a partnership with Monash University on the MAGNET study, which explores deep phenotyping in children with autism, ADHD, or both. This large-scale family-based trial aims to refine BlinkLab's machine learning algorithms to better differentiate between autism and ADHD clinical features, with preliminary results expected by late 2025. Additionally, a separate ADHD study in the Netherlands is underway, further enhancing the company's diagnostic capabilities.

Financial Position and Outlook

As of December 31, 2024, BlinkLab reported a cash balance of A$4.4 million, with net cash used in operations totaling A$0.963 million for the quarter, primarily directed towards research and development. The company continues to invest strategically in clinical studies, regulatory activities, and technology improvements, supported by recent capital raises. Directors have also demonstrated confidence by purchasing shares on-market.

With final FDA study results expected by the end of 2025 and regulatory approval targeted for mid-2026, BlinkLab is poised at a critical juncture. Success could redefine early autism diagnostics, leveraging accessible smartphone technology to enable earlier intervention and improved outcomes for children worldwide.