• US Ethics Approval: BlinkLab obtains Institutional Review Board (IRB) approval for main phase of FDA 510(k) diagnostic trial
• FDA 510(k) Diagnostic Trial: Study to be conducted across multiple US sites with up to 1,000 participants
• Onboarding New Sites: At least 8 autism centers expected to be onboarded with IRB approval

BlinkLab Limited (ASX:BB1), a leading digital healthcare company specializing in AI-powered diagnostics, has announced that it has received Institutional Review Board (IRB) approval for the main study phase of its FDA 510(k) diagnostic trial evaluating the BlinkLab Dx 1 technology. This technology is designed to serve as an aid in the detection and diagnosis of autism. The IRB approval was granted by WCG, an established clinical research review organization based in Princeton, NJ, with extensive experience overseeing multi-site clinical trials. The BlinkLab study has been classified as minimally invasive and is therefore exempt from most requirements under the Investigational Device Exemption (IDE) regulations. This streamlines the path forward for the company. The main study phase will be conducted across multiple clinical sites in the United States and will include up to 1,000 participants. With the IRB approval secured, at least eight autism centers are expected to be onboarded, as IRB approval was a prerequisite for most of these participating sites to sign the Clinical Trial Agreement (CTA) and proceed to site activation and participant recruitment. The results of the pilot study are expected to be released in the third quarter, allowing time for physician assessments using the reference standard method.