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BlinkLab (ASX:BB1) Signs Partnership with European INTER-PSY for Clinical Trial, Supporting US and EU Regulatory Approval and Future Market Adoption

Jane Morgan Management 3 mins read

Sydney, Australia – 12 September 2024 | BlinkLab Limited (ASX: BB1) (“BlinkLab” or “the Company”), an innovative digital healthcare company developing AI-powered sensory assessments on smartphones for detecting neurodevelopmental conditions, is pleased to announce a partnership with INTER-PSY in the Netherlands. The new partnership will facilitate a prospective clinical trial for the early diagnosis of autism in children aged 2-6 years old, aiding BlinkLab on its path to both US and European regulatory approval and eventual market adoption.

Highlights:

  • Clinical Trials with INTER-PSY: The partnership will see INTER-PSY conducting a study to evaluate the effectiveness of BlinkLab’s technology for aiding autism diagnoses in children. This trial hopes to optimise BlinkLab’s experimental parameters and AI algorithms.

  • Aiding and Accelerating Regulatory Approval: The clinical data from this trial will be crucial for advancing BlinkLab’s regulatory approval efforts in the US and EU, including the upcoming FDA 510(k) registration trial which take place later this year.

  • Addressing Autism for Females: As part of the SCANNER consortium, the study will also specifically target accelerated autism diagnosis in females, a critical issue due to the underrepresentation that is currently in diagnostic methods used today.

Els Blijd-Hogewys, INTER-PSY, commented: “INTER-PSY is committed to supporting young children with autism in an efficient and effective manner. Our goal is to implement a ‘no waiting time policy’ between diagnosis and the start of therapy, working collaboratively with clients to help them take control of their lives and minimise the impact of autism on daily tasks. Integrating objective measurements can help in the diagnostic process, offering significant benefits to children, their families, and our providers. We believe that BlinkLab's innovative AI platform presents a promising solution for sensory assessments in autism, delivering a short, pleasant and child-friendly test experience. Research will be conducted at INTER-PSY's Expertise Team for Young Children (<6 years). In the future, the instrument could also be valuable for adults with autism. Unfortunately, the waiting lists for autism assessment for adults in the Netherlands are often as long as 2 to 3 years. Such an instrument may help accelerate this process.” 

Brian Leedman, Chairman of BlinkLab, stated: “Australia has comparable wait times for diagnosis of autism as experienced in Europe and the US. Our BlinkLab technology has the potential to significantly reduce wait times through early diagnosis resulting in treatment at a formative age where early intervention can lead to better outcomes for children and their caregivers.” 

Dr. Henk-Jan Boele, CEO of BlinkLab, added: “Our collaboration with INTER-PSY is one of the final steps in the prospective validation of BlinkLab’s platform before we commence our FDA registration trial later this year. I’m deeply appreciative of INTER-PSY’s partnership on this critical journey. As part of the large SCANNER consortium in Europe, this study with INTER-PSY will also specifically address autism diagnosis in females. Our BlinkLab team is in the final phase of fine-tuning our AI models and algorithms to ensure they meet the highest standards of accuracy, safety, and efficiency. We remain fully committed to executing our strategy and delivering long-term value to all our stakeholders.” 

About the SCANNER Consortium:

The SCANNER Consortium, of which BlinkLab is a member, recently received a €5.3M grant from the Dutch Research Council. The consortium’s mission is to investigate sex differences in autism diagnosis, aiming to address diagnostic biases and improve outcomes for females with neurodevelopmental conditions.

Dr. Henk-Jan Boele
Chief Executive Officer
henkjan@blinklab.org

Brian Leedman
Non-Executive Chairman
brian@blinklab.org

Jane Morgan
Investor & Media Relations
jm@janemorganmanagement.com.au


About us:

About BlinkLab Limited:

BlinkLab, a company founded by neuroscientists at Princeton University, over the past several years has fully developed a smartphone based diagnostic platform for autism, ADHD, and other neuropsychiatric conditions. BlinkLab’s most advanced product is an autism diagnostic test that leverages the power of smartphones, neuroscience and AI to deliver screening tests specifically designed for young children. This marks a significant advancement, considering traditional diagnoses typically occur around five years of age, often missing the crucial early window for effective intervention. BlinkLab is led by an experienced management team and directors with a proven track record in building companies and vast knowledge in neuroscience, digital healthcare, computer vision, AI and machine learning. Our Scientific Advisory Board consists of leading experts in the field of autism and brain development allowing us to bridge the most advanced technological innovations with groundbreaking scientific research. 


Contact details:

Jane Morgan
Investor & Media Relations
jm@janemorganmanagement.com.au

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