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How BlinkLab’s Dx 1 Smartphone Test Surpassed FDA Benchmarks in Autism Diagnosis
9:39am on Wednesday 22nd of October, 2025 AEDT
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Healthcare
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How BlinkLab’s Dx 1 Smartphone Test Surpassed FDA Benchmarks in Autism Diagnosis
9:39am on Wednesday 22nd of October, 2025 AEDT
Key Points
Completed U.S. pilot study with 485 children aged 2-11
Achieved 83.7% sensitivity and 84.7% specificity, exceeding FDA thresholds
FDA endorsed streamlined pivotal 510(k) study with reduced enrollment to 528 participants
Identified novel digital markers to enhance diagnostic accuracy
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