WA’s BlinkLab secures first US clinical trial site for smartphone autism test
WA telehealth startup BlinkLab has secured its first clinical trial site in the US as it works toward a Food and Drug Administration approval.
Shares extended its record run on Wednesday after BlinkLab announced it had signed up Ohio-based medical centre PriMED as part of its autism registrational trial, which is seeking to recruit a total of 1000 participants.
BlinkLab hopes to commercialise a smartphone app to help diagnose autism and attention deficit hyperactivity disorder (ADHD) in young children.
The company is chaired by Brian Leedman, who co-founded ResApp Health, which used a similar technology as a diagnostic tool for respiratory problems. It was bought by US giant Pfizer for nearly $200 million in September 2022.
Mr Leedman is confident of BlinkLab’s ability to recreate ResApp’s success.
“I think that this type of technology is highly appealing to the large technology companies, such as the big pharmas, Apple Health, Google Health,” he said.
When asked he if was open to BlinkLab being acquired, Mr Leedman said: “For the right price, absolutely”.
Over the past six months, BlinkLab shares have surged 77 per cent to 42.5¢.
BlinkLab chief executive Hendrikus-Johannes Boele described the announcement as the “official initiation of our 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.
The company said multiple other clinical and research sites in the US were nearing the final stages of contract negotiations.
“(Having) many more hospitals . . . across North America is really important to demonstrate to the FDA that the patient we’re recruiting come from all different creeds and colours, to show that the technology works across a nice racial spread, Mr Leedman said.
PriMED is expected to commence patient recruitment and testing this month. BlinkLab anticipates FDA approval early next year.
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