BlinkLab (ASX:BB1) is developing a mobile app-based platform to diagnose neurological disorders in children, including autism and ADHD. The technology, which originated from neuroscience research at Princeton University, aims to provide a more accessible and cost-effective diagnostic tool compared to traditional methods.
Technology and Development
BlinkLab's diagnostic platform utilizes a mobile app to collect data and a portal to analyze the data and customize tests. The app assesses brain function through biomarker detections, computer vision, and facial reflex analysis in response to visual and auditory stimuli. The company has already completed approximately 6,000 individual tests using its technology.
According to BlinkLab, their technology can diagnose children as young as 18 months of age, paving the way for early intervention. This is particularly significant given that traditional autism diagnoses often occur later, potentially delaying access to crucial therapeutic interventions.
Clinical Trials and Regulatory Pathway
BlinkLab is planning a clinical trial to secure FDA approval for its autism diagnostic app. The trial, conducted in collaboration with Dutch company INTER-PSY, will assess the app's ability to diagnose autism in children aged 2 to 6 years. Enrollment is expected to begin later this year, with the company aiming to submit its application to the FDA by mid-2025, potentially leading to approval in the first quarter of 2026.
Market Opportunity and Impact
The prevalence of autism has been increasing, with current estimates suggesting that 2-4% of children are affected. The costs associated with autism are substantial, estimated at $60,000 during childhood and $3.6 million over a lifetime for individuals with conditions on the autism spectrum. Traditional autism evaluations can cost between $1,000 and $5,000 and may involve lengthy waiting periods.
BlinkLab aims to address this unmet need by providing a more affordable and accessible diagnostic tool that can facilitate earlier intervention and improve outcomes for children with autism. The company also plans to pursue CE Mark approval in Europe and establish a commercial launch strategy, including seeking reimbursement codes and support from key opinion leaders.
Leadership and Expertise
BlinkLab's board includes Brian Leedman, the former chairman of ResApp (ASX:RAP), a smartphone app that diagnosed respiratory diseases and was acquired by Pfizer in 2022. Leedman's experience in the development and commercialization of app-based health technologies could prove valuable to BlinkLab as it navigates the regulatory and market landscape.
Risks and Challenges
BlinkLab faces the risk that its clinical trial may not be successful or that the app may require further refinement. The company must also navigate the regulatory approval process and establish a viable commercialization strategy. However, if BlinkLab can successfully validate its technology and bring it to market, it has the potential to significantly improve the lives of children with autism and their families.
