Cognoa has initiated a pivotal study to show the effectiveness of its diagnostic aid for autism spectrum disorder (ASD).

It expects to submit the results of this multi-site, prospective, blinded, active comparator study to the US Food and Drug Administration (FDA) in 2020.

The US-based pediatric behavioural health company claimed that its digital diagnostic has the potential to become the first cleared medical device to help detect autism.

The device is expected to enable doctors in primary care to diagnose autism in children as young as 18 months. Early diagnosis will enable children to receive earlier treatment.

Children are currently diagnosed for autism at an average age of four years and four months. This period is following the primary window of brain development when any kind of interventions would have the maximum impact.

Cognoa is engaged in the development of AI-powered digital therapeutics and medicines to boost pediatric behavioural health. It secured FDA Breakthrough Device designation for its two lead products, a digital diagnostic for autism and a digital therapeutic to treat autism. This designation offers priority review for clearance by the FDA.

Cognoa CEO Brent Vaughan said: “Cognoa believes digital therapeutics can fundamentally improve the standard of care for pediatric behavioural health. Our breakthrough products will empower both parents and their trusted family physicians so that every child can receive an earlier diagnosis and treatment when there is the greatest ability to impact the child’s development and improve lifelong outcomes.

“Building upon Cognoa’s previous successful clinical studies, this pivotal study is an important milestone for our company. In tandem, we have established our commercial model with our partner, EVERSANA, that will enable access to our digital therapeutics by physicians through existing prescription, distribution and reimbursement infrastructures for utmost efficiency.”

Cognoa chief medical officer Dr Sharief Taraman said: “The current system does not serve children with autism or families who are concerned about their child’s development. Barriers to treatment will not change as long as access to diagnosis and treatment stays heavily reliant on specialty care, where we face a growing shortfall.”

According to a study published last month, commonly used screener M-CHAT was found to be less effective in detecting autism than earlier indicated, the company claimed.

Another study also indicated that over two-thirds of children with autism were not referred to a specialist for treatment.