The first part of this study will assess the initial 100 patients, aged between 2-11 years, which will include children with and without autism. The aim of the lead-in to the main study is to ensure the procedures in place at the sites are appropriate to achieve results similar to previous studies.
The most recent study results from a trial conducted in the US and Morocco in 441 children showed that the diagnostic achieved a sensitivity of 91% and a specificity of 85%, the latter being particularly important according to CEO Henk-Jan Boele.
The lead-in study will also allow changes to the trial protocol and the algorithm, prior to moving into the main study, which will seek to recruit between 750 - 900 additional subjects.
Results from the first 100 subjects are expected by mid year. Results from the main study are expected towards the end of this year with the company seeking to file the diagnostic for approval with the FDA in early 2026, pending positive results.
At the Broker Meets Biotech presentation this week in Perth, Boele – who is a former physician and neuroscientist – said that for parents of children with autism, it is a rollercoaster pathway whereby the children are passed from specialist to different healthcare practitioners to diagnose the condition. There is currently no biomarker test for autism.
Boele said that the prevalence of autism has increased to 2.4%, with the lifetime cost being $3.6 million per person. The benefit of earlier diagnosis, according to Boele, is that it enhances the inde- pendent living skills when the child becomes an adult.
In Australia, 35% of people receiving NDIS assistance have autism, which contributes to an annual cost of $8.4 billion. This funding increased by 28% in 2023 and by 22% in 2022.
Additional Ongoing Programs
Blinklab has two other programs under way. One is in the Netherlands, using its technology to assess up to 500 children with ADHD. The company expects a pivotal US study to start next year in ADHD, pending a positive outcome from the current program.
It is also working with Monash University. That program is seek- ing to recruit up to 1,000 families that have children diagnosed with autism or ADHD, with a view to assess the remaining family (presumably to seek to establish a familial link).
Last week the company announced an additional study in the Netherlands in an adult population, with previous studies having concentrated on children. This study will seek to enroll around 200 subjects, half with autism and half being controls. The com- pany notes that the blinking responses from adults and children differs, requiring an adjusted algorithm. The study will also seek to explain why autism diagnosis in men is four times higher than in women, which may be due to the limited medical assessment processes currently available.
That study is being run in conjunction with the Dutch Autism Association which has an active database of 6,800 people who have been diagnosed with autism.
Blinklab is capitalized at $40 million with $4.4 million in cash at the end of last year. Additional funding will be required by the company.
Bioshares recommendation: Speculative Buy Class B
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