Blinklab (BB1: $0.785) has been requested by the Moroccan government to provide its smartphone-based autism test to form part of a national screening program in the country for all children above the age of 18 months.
At this point the deal will not be a revenue generator for Blinklab, other than having its costs covered by the government. The commercial terms may change upon regulatory approval. However the key benefit for Blinklab is real world experience in administering and managing distribution of the test.
Blinklab has had a long association with Morocco with some of its key staff being from the country. In January this year, a paper was published in the journal Autism Research detailing the results from a study involving 536 children aged between 8-12 years at eight different locations in Morocco.
That study showed that a smartphone based test can be used to generate an objective assessment of children with autism. "Our results serve as a starting point from which to investigate the diagnostic accuracy of accessible technology in future prospective clinical trials"
Since that study, the company has completed several trials, including a lead into its pivotal US study which delivered a sensitivity of 83.7% and a specificity of 84.7%, which is well in excess of the 65% performance hurdle required for a commercial test according to the company.
This week Blinklab commenced its pivotal validation study for FDA approval, which will seek to recruit 528 children across 10 sites. All 10 sites in the US have been onboarded with the first subject having now been assessed.
The trial is expected to take up to eight months to recruit. The company is aiming to file the product for approval before the end of the year with the FDA for use as an aid in the diagnosis of autism and to support decision making by medical practitioners.
The aim of early diagnosis and then early intervention of autism is to improve patient management and progression of the disorder. Chairman of Blinklab Brian Leedman believes that Morocco is leading the way in addressing the looming funding blowout required to support the growing burden of autism management on healthcare budgets. "In relation to Australia's own NDIS, an adult receives more than three times the level of funding support than a child. This represents a tsunami of funding to support the current wave of children being diagnosed with autism growing into adulthood."
Dr Kahlid Benhassan, Director of the Mohammed IV National Center for the Disabled in Morocco said: "Thanks to the simplicity and accessibility of smartphone technology, Blinklab makes early screening from as young as 18 months not only clinically reliable, but also practical and deployable across various healthcare and community settings".
In Morocco around 400,000 people are believed to have autism with 600,000 children born each year.
Blinklab is capitalized at $99 million with $5.5 million in cash at the end of last year.
Bioshares recommendation: Speculative Buy Class A
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