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Blinklab Makes Further Improvements to Autism Diagnostic Ahead of Pivotal US Study

 

 

 

Blinklab (BB1: $0.28) has added some additional image & vocal assessments into its autism diagnostic.

 

The company listed in April this year. In a previous study in 280 children, its smartphone-based test showed a very good sensitivity of 84% and specificity of 85%.

 

The addition of the extra measures, including head movements and vocal responses, has achieved an increase in sensitivity to 91% with specificity remaining similar, at 85%. The latest study, which commenced in 2023 in Morocco and the US, included 441 children.

 

Blinklab intends to start its US pivotal study, in approximately 500 children, by year's end. That study is expected to take around 12 months to complete, with an FDA submission for approval shortly thereafter, and a decision from the regulator expected possibly in mid 2026 if all goes well.

 

Blinklab is capitalized at $27 million with $5.4 million in cash at the end of September.

 

Bioshares recommendation: Speculative Buy Class B

 

 

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