• Pilot Study Completion and Unblinding: BlinkLab has successfully completed its U.S. Pilot Study of the Dx 1 diagnostic device, involving 485 children
• Strong Diagnostic Performance: BlinkLab Dx 1 achieved 83.7% sensitivity and 84.7% specificity relative to clinical reference diagnosis
• Performance Exceeds FDA Benchmark for Registrational Study: The FDA confirmed a minimum performance threshold of >65% sensitivity and >65% specificity for regulatory clearance

BlinkLab, a leading digital healthcare company focused on AI-powered diagnostics, has announced the successful completion of its United States pilot study evaluating the Company's smartphone-based digital diagnostic test for autism spectrum disorder, BlinkLab Dx 1. The Pilot Study enrolled 485 children, aged between 2 and 11 years, with a broad range of developmental profiles, including those with clear autism presentations to others with mild, overlapping, or subthreshold developmental characteristics. Despite this clinical heterogeneity, the BlinkLab Dx 1 model demonstrated strong performance, achieving 83.7% sensitivity and 84.7% specificity relative to gold-standard clinical assessments. This performance exceeds the FDA's minimum threshold of >65% sensitivity and >65% specificity for regulatory clearance. The FDA has also approved BlinkLab's updated recruitment strategy for the upcoming 510(k) pivotal study, which will involve 528 participants across leading U.S. autism research centers. The analysis of the Pilot Study data also identified new potential digital markers that are expected to further enhance the diagnostic accuracy, robustness, and clinical interpretability of the BlinkLab Dx 1 device.

BlinkLab remains on track of submitting a 510(k) clearance application to the FDA next year for the BlinkLab Dx 1 device.

With the Pilot Study now complete and optimization underway, BlinkLab is well-positioned to transform early diagnosis of neurodevelopmental conditions by delivering two 15-minute, smartphone-based tests that can bring clinical-grade assessment into homes, clinics, and primary care settings worldwide.