BlinkLab

Positive Outcome from FDA Pre-Submission Meeting

BlinkLab Achieves Pivotal Step Towards FDA Approval for Autism Diagnostic App

BlinkLab Limited (ASX:BB1) (“BlinkLab”, or the “Company”), an innovative digital healthcare company 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 in order to achieve 510(k) clearance and subsequently launch the diagnostic app in the U.S. The Company plans to complete both programs within 12-16 months after the necessary approvals and site engagements have been secured.


Highlights

  • Positive outcome received from a Pre-Submission meeting with the U.S. Food and Drug Administration (“FDA”) regarding the regulatory pathway for BlinkLab Dx 1 diagnostic app.
  • The FDA has confirmed the design for the BlinkLab Dx 1 registrational program, which will consist of an Initial Study Phase that then transitions into the Main Study. The Initial Phase will recruit up to 100 children with the main registrational study up to 1,000 subjects recruited from up to ten clinical sites.
  • Several leading clinical sites across the U.S. have already been selected with ethics submission and site activation in process.
  • The initial phase (of 100 children) will be used to:
    • Familiarise the investigators and personnel at clinical sites.
    • Train in-person and virtual recruitment strategies.
    • Test the procedures of subjects screening and data collection.
  • 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.
  • FDA has confirmed the study protocol, statistical analysis plan, clinical endpoints and final data requirements to achieve 510(k) clearance for “BlinkLab Dx 1” as an aid in the diagnosis of autism.

U.S. FDA registrational study in Autism Underway

To support its FDA registration in the US, BlinkLab has initiated a large clinical study in 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 final clinical study design and data requirements in order to achieve FDA 510(k) clearance. Clinical site selection is in progress with ethics approvals and onboarding about to be complete for several sites.

The upcoming clinical program will consist of an Initial Study Phase that will precede the main registrational study. The Initial Study Phase will enrol 100 subjects with the main study continuing recruitment of up to 1,000 children with autism 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 programs within 12-16 months after the necessary approvals and site engagements have been secured. This 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.

Both phases of the study will incorporate a prospective, double-blinded, within-subject comparison design in order 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 study, should data meet the accuracy outputs, BlinkLab will submit the study report and supporting documentation for FDA 510(k) clearance in order to gain access to the U.S. autism diagnostic market.

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 Dx1 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 BlinkLab, commented:"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."


Click here for the full ASX Release

This article includes content from Blinklab Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.

BB1:AU
BlinkLab Limited

BlinkLab Limited Investor Kit

  • Corporate info
  • Insights
  • Growth strategies
  • Upcoming projects

GET YOUR FREE INVESTOR KIT

The Conversation (0)
BlinkLab Limited

BlinkLab Limited


Keep reading...Show less

Revolutionising Mental Health Care Through Mobile Solutions

US Autism Diagnostic Study Commences with First Child Tested

US Autism Diagnostic Study Commences with First Child Tested

BlinkLab Limited (BB1:AU) has announced US Autism Diagnostic Study Commences with First Child Tested

Download the PDF here.

Man holding magnifying glass.

Tech 5: CoreWeave IPO Falls Short, OpenAI Close to Completing US$40 Billion Funding Round

This week brought a fresh set of challenges to the tech sector, beginning with an announcement from the US Bureau of Industry and Security on Tuesday (March 25) of new export restrictions targeting 80 companies across Asia and the Middle East, impacting some of Big Tech’s key customers.

Consumer confidence weakened, further dampening market sentiment.

This was evidenced by the release of the Conference Board’s Consumer Confidence Index report on Tuesday, and the University of Michigan’s consumer sentiment survey, released on Friday (March 28).

Keep reading...Show less
Hand holding an AI chip.

Global AI Stocks: 9 Biggest Companies in 2025

As the artificial intelligence (AI) market continues to grow, there are many AI stocks for investors to choose from on top exchanges like the NASDAQ, TSX and ASX.

AI technology has made strong inroads into several key industries, including logistics, manufacturing, finance, healthcare, customer service and cybersecurity.

The technology has been around for a long time, but this current wave of buzz comes after the release of OpenAI’s ChatGPT, a generative AI platform. This intelligent chatbot shows how quickly generative AI is advancing, and it has led to many other major tech firms entering the space with their own generative AI offerings or including AI technology into their innovative products.

Keep reading...Show less
RocketBoots

RocketBoots Partners with Global POS Software Vendor to Drive Customer Markets Penetration

Artificial Intelligence software company, RocketBoots Limited (ASX:ROC) (RocketBoots or the Company), is pleased to announce the signing of a partnership agreement with global point-of-sale (POS) vendor, GEBIT Solutions GmbH (Gebit).

Keep reading...Show less
AI chip.

Tech 5: CoreWeave Sets IPO Date, Google to Acquire Wiz

The tech landscape presented a dichotomy this week: company growth juxtaposed with market volatility over concerns that US President Donald Trump’s tariffs could upend global trade and lead to a recession.

“Inflation has started to move up,” US Federal Reserve Chair Jerome Powell said after a two day meeting that culminated in the interest rate target remaining between 4.25 and 4.5 percent.

“There may be a delay in further progress over the course of this year,” he added.

Keep reading...Show less
Decidr AI Industries

AWS Strategic Partnership & Equity Raising

Decidr AI Industries Ltd (ASX: DAI) (“the Company”), is pleased to announce that Decidr.ai Pty Ltd (“Decidr”) has engaged in a multi-part strategic partnership with Amazon Web Services (“AWS”) to accelerate AI-powered business transformation and the adoption of Decidr Agentic technology.

Keep reading...Show less
BlinkLab Limited

BlinkLab Limited Investor Kit

  • Corporate info
  • Insights
  • Growth strategies
  • Upcoming projects

GET YOUR FREE INVESTOR KIT

Latest Press Releases

Related News

×