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BlinkLab Ltd

1/22/2025

 
Invention: Autism/ADHD diagnostic app
Trademark: BlinkLab
Patents: 4
FDA Approved: No
Pathway: Class II 510(k)
ASX: BB1

The Invention

BlinkLab is an Australian-based company developing an AI-powered smartphone app for early-stage detection of autism and ADHD. The app generates visual and auditory stimuli that evoke facial expressions and reflexes in the user. These expressions are used as biomarkers for the diagnosis of autism and ADHD. The platform has been validated in over 8,000 subjects globally, and is currently used by academic and clinical institutes. 

​Current autism diagnostic evaluations are subjective tools, the costs of diagnosis are between $1,000-$5,000 and require multiple specialists (psychologists, audiologists, occupational therapists, etc.), and waitlists can range from 12-24 months. In contrast, BlinkLab can be used at home, the tests are priced at $200, and the app provides an instantaneous diagnosis that is confirmed by clinicians within 1-2 months. 

Prevalence

According to CDC's Autism and Developmental Disabilities Monitoring (ADDM), 2.7% of children are diagnosed with Autism Spectrum Disorder (ASD).

Performance advantages

​Other Machine Learning solutions to ASD diagnosis include:
  • Canvas Dx™ by Cognoa: an FDA approved smartphone app that involves filling out a questionnaire and filming the subject during cognitive tasks​
  • EarliPoint™ by EarliTests Diagnostics Inc: an in-clinic console-based device that  analyzes the subject's responses to video presentations

According to the company, BlinkLab outperforms both solutions in both sensitivity and specificity.  


​Another neurometric approach is called prepulse inhibition (PPI). While effective in diagnosis, PPI is only administered in specialized labs and involves attaching bulky and uncomfortable equipment to the subject's face. Because it is technically complex to administer, it has not been implemented in clinical practice. 

​Regulatory pathway

The company expects to submit its 510(k) for ASD by Q4 2025, and to receive approval in Q2 2026. 

Intellectual Property
​
As of Q4 2024, the company holds the following US patents:
  • Exclusive license to US patent registered to Princeton University: 18/036,009 Filed May 9, 2023, entitled “System and Method for Remote Neurobehavioral Testing”
  • Provisional patent application number 63/218,607 Filed on November 30, 2022, entitled “Psychopharmacological System and Method Using Eyelid Tracking”
  • Provisional patent application number 63/460,451 Filed on April 19, 2023, entitled “Method And System For Measuring Emotional Engagement”
  • Provisional patent application number 63/548,542 Filed on February 1, 2024, entitled “System And method For Detecting Neurological Condition”

Sources

BlinkLab corporate presentation 2024: ​6758d14b5d8fdb15a4c7e45e_Blinklab Pitchdeck 2024.pdf

​Prevalence and Characteristics of Autism Spectrum Disorder Among Children Aged 8 Years — Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States, 2020 Surveillance Summaries / March 24, 2023 / 72(2);1–14

https://www.theaustralian.com.au/business/stockhead/content/blinklab-gains-fda-support-for-trial-of-app-aiding-autism-diagnosis/news-story/5d9d6bee901d7c6811d2370db8108bec

https://www.theaustralian.com.au/business/stockhead/content/lodge-partners-sees-430-upside-for-blinklab-developer-of-smartphone-autism-test/news-story/3a9287f076afb26dd2ba1e892575e77a

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