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BlinkLab Launches FDA Autism Diagnostic Trial Backed by Strong Early Data
6:46pm on Sunday 1st of June, 2025 AEST
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Healthcare
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BlinkLab Launches FDA Autism Diagnostic Trial Backed by Strong Early Data
6:46pm on Sunday 1st of June, 2025 AEST
Key Points
Initiation of FDA registrational study with up to 1,000 participants
Positive FDA pre-submission feedback on study design and regulatory pathway
Strong pivotal study results showing 91% sensitivity and 85% specificity
Partnership with Monash University on autism and ADHD genetics study
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