BlinkLab initiates first US clinical sites for autism registrational study

Two leading US-based autism centres have joined Blinklab’s autism diagnostic registrational trial.

Two leading US-based autism centres have joined Blinklab’s autism diagnostic registrational trial. Image: Getty.

• The first two US-based sites join BlinkLab’s autism diagnostic registrational trial

• PriMED and North Shore Pediatric Therapy expected to start recruitment and testing in February

• Registrational study will evaluate BlinkLab’s Dx 1 platform as an aid in the diagnosis of autism

Special Report: Two leading US-based autism centres have joined BlinkLab’s autism diagnostic registrational trial with the paediatric division of Southwest Ohio-based PriMED Clinical Research the first to join followed by North Shore Pediatric Therapy (NSPT) in Chicago.  

Medtech BlinkLab (ASX:BB1) said PriMED and NSPT provided access to a large pool of diverse children that will accelerate the recruitment process and ensure high-quality data collection for the registrational study.

BlinkLab said PriMED Clinical Research was selected due to its extensive experience in clinical studies for both paediatric and adult populations with a goal of enrolling up to 15-20 participants each month.

The company said NSPT was selected for the study due to its extensive expertise in administering the ADOS-2 diagnostic tool, which is widely recognised as the gold standard for autism diagnosis.

“As part of our US registrational study, NSPT’s use of the ADOS-2 will serve as a critical benchmark for standard-of-care comparisons, helping validate the effectiveness of our Blinklab Dx 1 test,” BlinkLab said in its announcement.

BlinkLab revealed both the PriMED and NSPT clinical trial sites were expected to start patient recruitment and diagnostic testing in February, supporting timely and efficient data collection for the initial phase.

The registrational study will evaluate BlinkLab’s Dx 1 platform as an aid in the diagnosis of autism with the initial phase recruiting up to 100 participants (children aged between 2-11 years old), with the main study recruiting up to 1000 subjects.

Significant milestone for BlinkLab

BlinkLab said initiation of these first sites marks a significant milestone in its registrational study and paves the way for subsequent phases.

The company said it had been proactively initiating partnerships with 16 sites, spanning across the entire US during the Institutional Review Board (IRB) approval processes for the study.

The parallel approach has allowed BlinkLab to expedite the launch of the clinical trials once all necessary approvals are in place.

BlinkLab said the final results of the registrational study were expected by the end of CY25 and would be used for the 510(k) FDA approval.

Positive results from previous studies

BlinkLab Dx 1 is a platform that 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.

Analysis of a study released in November 2024 conducted in 441 children diagnosed for autism using current standard-of-care protocols showed that the BlinkLab Dx 1 platform detected autism with an improved sensitivity of 91% and specificity of 85%.

‘Transform early detection of autism’

PriMED MA-CCRC clinical research site manager Crystal Jackson said PriMED physicians and the PriMED clinical research team, alongside principal investigator Dr Rogelio Amisola, were looking forward to its collaboration with BlinkLab.

“This partnership represents an exciting opportunity to integrate our clinical expertise with BlinkLab's innovative AI technology,” she said.

“We are dedicated to providing accurate and detailed data for the advancement in healthcare, paving the way for innovative approaches that enhance diagnostic accuracy and improve patient outcomes.”

BlinkLab CEO Dr Henk-Jan Boele said he was excited to announce the official initiation of the company’s FDA work.

“By partnering with the best clinical institutions, BlinkLab is committed to delivering breakthrough, accessible AI-driven technology that is expected to transform early autism detection and provide families with faster, more reliable diagnoses,” he said.

Non-executive chairman Brian Leedman said since the company’s IPO in April 2024 the BlinkLab had made significant strides in advancing the AI smartphone-based diagnostics application.

“The initiation of our FDA registrational study for BlinkLab Dx 1, supported by positive results from pivotal studies, is a key milestone in bringing earlier and more accessible autism diagnosis to families,” 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.

Originally published as BlinkLab initiates first US clinical sites for autism registrational study