BlinkLab is pleased to announce a positive outcome from its Pre-Submission meeting with the FDA yesterday. The FDA has confirmed the study design and data requirements needed to achieve 510(k) clearance and subsequently launch the diagnostic app in the US.
The Company plans to complete both programs within 12–16 months after securing the necessary approvals and site engagements.
US FDA Registrational Study in Autism Underway
To support its FDA registration in the US, BlinkLab has initiated a large clinical study involving children with autism. The goal of the study is to obtain FDA 510(k) clearance for BlinkLab Dx 1 to serve as a digital diagnostic aid for autism. BlinkLab has received positive feedback from the FDA on the final clinical study design and data requirements necessary to achieve clearance.
Clinical site selection is in progress, with ethics approvals and onboarding nearing completion for several sites.
Study Design and Timeline
The upcoming clinical program will consist of two phases:
1. Initial Study Phase: This phase will enroll 100 subjects to ensure the study design and protocols are robust.
2. Main Registrational Study: Recruitment will continue with up to 1,000 children aged 2–11 years old.
The FDA trial will involve leading clinical and research sites across the US, ensuring a diverse population of children in terms of race, ethnicity, and gender. BlinkLab plans to complete both phases within 12–16 months after the necessary approvals and site engagements have been secured.
This dual-study approach ensures that clinical experts and participating families are fully trained and familiar with the BlinkLab Dx 1 diagnostic application and its functionalities.
Methodology and Regulatory Submission
Both phases of the study will incorporate a prospective, double-blinded, within-subject comparison design to establish BlinkLab’s diagnostic accuracy. This will involve comparing BlinkLab Dx 1 output to DSM-5-based diagnostic standards.
Upon completion of the study, should the data meet the required accuracy standards, BlinkLab will submit the study report and supporting documentation for FDA 510(k) clearance to gain access to the US autism diagnostic market.
Leadership Insights
Brian Leedman, Chairman of BlinkLab, commented on the milestone:
“This pivotal outcome in our FDA regulatory study process marks a significant milestone in our achievements as a listed Company. With this guidance from the Pre-Submission Meeting, we are confident in our study design and ability to bring BlinkLab Dx 1 to market. We look forward to updating the market in early 2025 as to our progress in site selection, recruitment, and results of the initial study.”
Henk-Jan Boele, CEO of BlinkLab, added:
“I am pleased that we had such a productive discussion with the FDA regarding our regulatory trial. Truly appreciate their support and alignment on addressing the unmet medical need. We look forward to collaborating closely with the FDA on advancing BlinkLab Dx 1.”
