Addressing Critical Gaps in Autism Diagnosis

Autism spectrum disorder (ASD) affects millions of children worldwide, yet early diagnosis remains a major challenge. Despite recommendations from the American Academy of Paediatrics (AAP) for autism screening at 18 and 24 months, many children experience delays in diagnosis, missing the crucial window for early intervention.

BlinkLab Limited (ASX:BB1) is working to bridge this gap with its AI-powered, smartphone-based diagnostic tool, BlinkLab Dx1. The company has now officially launched its pivotal U.S. clinical trial, aiming to validate the technology as a critical aid for early autism detection.

CEO Highlights the Significance of This Milestone

Dr. Henk-Jan Boele, Cofounder and CEO of BlinkLab, described the trial’s commencement as a defining moment for the company.

“Launching our U.S. trial marks a very special and important moment for BlinkLab,” Dr. Boele said. “Our mission has always been to connect fundamental neuroscience with clinical practice through accessible technology, thereby enhancing autism diagnostic evaluations and enabling early intervention for children.”

The first child has now been tested at PriMED Clinical Research LLC in Dayton, Ohio, marking the beginning of what will be the largest digital diagnostic trial for autism in the U.S.

Aiming for a Faster, More Accessible Autism Diagnosis

The BlinkLab Dx1 test is designed to provide healthcare providers with a rapid and reliable diagnostic aid. By using AI-driven assessments via smartphones, the technology aims to reduce the time between initial concerns and formal diagnosis.

PriMED Clinical Research, a research-focused arm of PriMED Physicians, is one of the first two clinical sites selected for the initial phase of the trial. North Shore Pediatric Therapy will also participate in the study.

“After extensive app and portal development, stimulus refinement, and testing in hundreds of children, we are very confident in our FDA study’s potential,” Dr. Boele said. “Early diagnosis is life-changing, and BlinkLab is dedicated to empowering families and healthcare providers with AI-driven tools for accurate, accessible, and timely autism assessments.”

Study Progress and Regulatory Pathway

The study will first enrol 100 participants, with initial data expected to be released in Q3 CY2025. Following this phase, the trial will expand significantly, with plans to enrol an additional 750 to 900 children.

The results will form the foundation for BlinkLab’s submission for FDA 510(k) clearance, which is anticipated at the end of CY2025. Regulatory approval will allow the company to enter the U.S. market and provide clinicians with a cutting-edge tool for early autism detection.

Clinical Research Team Backs the Technology

Crystal Jackson, Certified Clinical Research Coordinator and Site Manager for PriMED Clinical Research (PCR) emphasised the significance of this study for both the medical field and affected families.

“Dr. Rogelio Amisola, Principal Investigator, and PCR’s team of dedicated investigators & coordinators are thrilled to be the first U.S. site to screen participants in this monumental milestone for BlinkLab,” Jackson said. “We are hopeful our quality of data will assist BlinkLab Dx1 in advancing AI technology to support medical professionals in the early detection of autism—bringing innovation and hope to families everywhere.”

A Game-Changer for Early Intervention

BlinkLab’s work is set to revolutionise how autism and other neurodevelopmental disorders are diagnosed. With its AI-powered solution, the company is addressing a major gap in the healthcare system, ensuring children receive timely support during crucial developmental stages.

As the study progresses, all eyes will be on the upcoming data release in Q3 2025, which could further solidify BlinkLab’s position as a leader in digital diagnostics. With FDA clearance on the horizon, the company is on track to deliver a breakthrough in autism detection that could transform the lives of countless families.