How BlinkLab’s Dx 1 Smartphone Test Surpassed FDA Benchmarks in Autism Diagnosis

Pilot Study Completion and Diagnostic Performance

BlinkLab Limited (ASX, BB1) has announced the successful completion and unblinding of its U.S. pilot study evaluating the Dx 1 smartphone-based diagnostic device for autism spectrum disorder (ASD). The study enrolled 485 children aged between 2 and 11 years, representing a broad and clinically diverse population reflective of real-world pediatric neurodevelopmental concerns. The device demonstrated impressive diagnostic accuracy, achieving 83.7% sensitivity and 84.7% specificity relative to gold-standard clinical assessments.

This performance notably exceeds the minimum thresholds set by the U.S. Food and Drug Administration (FDA) for regulatory clearance, which require sensitivity and specificity above 65%. The pilot’s robust results underscore the device’s ability to detect autism even in complex cases with overlapping or subtle symptoms, a challenge that has historically limited digital diagnostic tools.

FDA Engagement and Streamlined Pivotal Study Design

In a formal meeting held just prior to unblinding, BlinkLab secured FDA endorsement of its pivotal 510(k) study protocol. The FDA approved a refined recruitment strategy that balances specialty autism centers with community referrals, enabling a more operationally efficient trial. This adjustment has reduced the planned enrollment from 1,000 to approximately 528 participants without compromising statistical power or data quality, promising significant cost and timeline savings.

The FDA’s acceptance of BlinkLab’s study design and performance benchmarks places the company on a clear regulatory pathway, with the pivotal trial set to commence shortly. This alignment is critical for BlinkLab’s ambition to bring its AI-powered, smartphone-based diagnostic tool to market.

Innovations in Digital Biomarkers and Clinical Relevance

Beyond confirming the device’s current accuracy, BlinkLab’s analysis of pilot data revealed potential new digital markers related to restrictive and repetitive behaviors; core features of autism that are challenging to quantify objectively. Incorporating these markers into the Dx 1 algorithm ahead of the pivotal study is expected to further enhance diagnostic precision and clinical interpretability.

Unlike earlier studies conducted in more narrowly defined cohorts, this pilot embraced the complexity and diagnostic uncertainty typical of everyday clinical practice. This real-world approach strengthens the relevance of BlinkLab’s technology, which leverages neuroscience, AI, and smartphone technology to provide objective, scalable assessments that could revolutionize early diagnosis and intervention.

Strategic Partnerships and Future Outlook

BlinkLab has secured collaborations with prestigious U.S. autism research centers, including Cincinnati Children’s Hospital, Seattle Children’s Hospital, and the University of Pennsylvania, among others. These partnerships will support the pivotal 510(k) study and reinforce the company’s position within the competitive digital diagnostics landscape.

Management expressed strong confidence in the technology’s readiness and the company’s mission to transform mental health diagnostics. With the pilot study behind them and the pivotal trial imminent, BlinkLab is poised to make significant strides toward FDA clearance and broader clinical adoption.