BlinkLab receives positive feedback from FDA. Pic via Getty Images.
Health & Biotech
Special Report: BlinkLab has announced a positive outcome from a pre-submission meeting with the US Food and Drug Administration (FDA) to support the registration of its Dx 1 platform as an aid in the diagnosis of autism.
BlinkLab (ASX:BB1) said the FDA confirmed the design for its BlinkLab Dx 1 registrational program and data requirements to achieve 510(k) clearance and subsequently launch the diagnostic app in the US.
The registrational program will consist of an initial study phase, which will recruit up to 100 children moving onto the main registrational study.
The main registrational study will recruit up to 1,000 children aged from two to 11-years-old from up to 10 clinical sites.
The company said the initial study phase will be used to:
The company said the dual study approach ensures that clinical experts on sites as well as families participating in the study are fully trained and familiar with the BlinkLab Dx 1 diagnostic application and its functionalities.
“These steps are part of the company’s strategy to de-risk the main FDA registrational study and to ensure the highest quality of the data collected and diagnostic accuracy of the BlinkLab app” the company noted.
BlinkLab said several leading clinical sites across the US have already been selected with ethics submission and site activation in process.
The biotech said the registrational trial would involve a diverse population of children in terms of race, ethnicity and gender.
BlinkLab plans to complete both the initial and main stages of the registrational study within 12-16 months after the necessary approvals and site engagements have been secured.
The registrational study will incorporate a prospective, double-blinded, within-subject comparison designed to establish BlinkLab’s diagnostic accuracy.
This will involve comparing BlinkLab Dx 1 output to the DSM-5 based diagnostic standards.
Following completion of the registrational study, should data meet the accuracy outputs, BlinkLab will submit the study report and supporting documentation for FDA 510(k) clearance to gain access to the US autism diagnostic market.
Founded by scientists from Princeton University, BlinkLab is a developer of smartphone and tablet apps to diagnose autism and attention deficit hyperactivity disorder (ADHD), schizophrenia, and other neurodevelopmental conditions.
BlinkLab said the Dx 1 platform uses advanced smartphone sensors to measure subtle changes in sensory responses, focusing on the brain’s reaction to unexpected sounds.
The company said the platform leveraged a known phenomenon in which individuals with ADHD and autism often exhibit different responses to unexpected sounds, such as blinking more frequently or differently compared to neurotypical individuals.
BlinkLab chairman Brian Leedman said the positive pre-submission meeting with the FDA was an important achievement for the company since first listing on the ASX in April.
“This pivotal outcome in our FDA regulatory study process marks a significant milestone in our achievements as a listed company,” he said.
“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”.
BlinkLab CEO Henk-Jan Boele said he was pleased the company had such a productive discussion with the FDA regarding its regulatory trial.
“We truly appreciate their support and alignment on addressing the unmet medical need and look forward to collaborating closely with the FDA on advancing BlinkLab Dx 1,” he said.
This article was developed in collaboration with BlinkLab, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
Health & Biotech
Health & Biotech
Health & Biotech
