BlinkLab Dx 1 Device Pilot Study Confirms High Diagnostic Accuracy and Readiness for FDA Trial

BlinkLab (ASX: BB1) has completed a US pilot study evaluating the smartphone-based Dx 1 diagnostic device for the assessment of behavioural and developmental concerns in children, including autism spectrum disorder and attention deficit hyperactivity disorder.

The unblinded study involved 485 clinically-diverse children aged between 2 years and 11 years, representing the full spectrum of developmental concerns, and included a community sample of children with no developmental concerns to provide a robust baseline for comparison and enabling evaluation of Dx 1’s sensitivity and specificity as primary end points.

BlinkLab compared the study results to independent clinical reference diagnoses provided by PriMED Clinical Research in Ohio and NorthShore Pediatric Therapy in Illinois, including the minimum 65% sensitivity and 65% specificity performance threshold for regulatory clearance by the US Food and Drug Administration.

Sensitivity and Specificity Results

The total cohort was a real-world sample of children with a broad range of developmental challenges, those with overlapping symptoms, and some with diagnostic uncertainty including mild or subthreshold presentations and very subtle social or sensory features.

The pilot study showed Dx 1 could achieve 83.7% sensitivity and 84.7% specificity across all participants relative to gold-standard clinical assessments including the autism diagnostic observation schedule, the childhood autism rating scale, and the social responsiveness scale.

Dx 1’s accuracy exceeded that of other FDA-approved digital diagnostic aids such as Cognoa (De Novo) and EarliPoint, placing BlinkLab in a strong position within the emerging digital phenotyping and AI-driven landscape.

Based on FDA feedback, BlinkLab has now refined its main 510(k) study to enrol approximately 528 children who are subject to neurodevelopmental assessment across leading US autism research centres, streamlining timelines and reducing cost.

Assessing Developmental Concerns

BlinkLab chair Brian Leedman said the pilot study results validated the strength of the company’s approach to assessing childhood developmental concerns.

“The learnings from this pilot give us the confidence that our pivotal study is likely to deliver the results needed for FDA clearance and ultimately, our technology will help millions of families access earlier, faster and more objective diagnosis” he said.

“Our patient recruitment efforts met with overwhelming interest, surpassing the original goal of 100 children and resulting in 485 participants which nearly matches the number we will be targeting for our upcoming FDA 510(k) study,” co-founder and chief executive officer Dr Henk-Jan Boele added.

“This pilot study marks the beginning of a new era in how neuroscience and technology come together to improve patient care, and we are excited to continue our mission to transform mental health diagnostics through accessible, objective and scalable digital tools.”

Early And Accurate Diagnosis

Dr Boele said Dx 1 could deliver early, accurate diagnosis in specialist clinics and would be scalable across communities and healthcare systems.

“Autism diagnosis still relies heavily on human interpretation and resource access, leading to delayed or inconsistent identification, particularly for those at the milder end of the spectrum,” he said.

“As global awareness and diagnoses rise, largely driven by less profound autism, the need for accessible, standardised and objective assessment tools has never been greater and Dx 1 is built to meet that challenge.”