FDA grants swift approval to Cognoa's digital device for autism diagnosis

Child on phone camera

The FDA has approved a digital device developed by Cognoa that can be used to diagnose autism spectrum disorder (ASD), just a few weeks after it was filed for approval.

Cognoa says the artificial intelligence (AI) based device is the first to be authorised by the US regulator that can help doctors diagnose autism in primary care, and will be launched "in the coming months".

At the moment, autism can be difficult to diagnose as there are no medical markers to confirm its presence. Instead, doctors have to look at a child's developmental history and behaviour over time before making a diagnosis.

While that process can be quite quick in severe cases of ASD, for the vast majority of children who are less affected it can take years to get a diagnosis, and in some countries waiting times for assessments are very long.

Cognoa thinks its Canvas Dx software as a medical device (SaaMD) could change this, providing an efficient and accurate assessment in primary care that would do away with the need for a lengthy referral to a specialist.

While autism can be reliably diagnosed in children as early as 18 months, the average age of autism diagnosis has remained at 4 to 5 years old for decades, according to the company.

It is estimated that ASD affects one in every 54 children in the US, with cases rocketing 178% since 2000 in part due to greater detection of milder forms, and increasing awareness of the neurodevelopmental condition.

"Autism spectrum disorder can delay a child's physical, cognitive and social development, including motor skill development, learning, communication and interacting with others," said Jeff Shuren, director of the FDA's Center for Devices and Radiological Health.

"The earlier ASD can be diagnosed, the more quickly intervention strategies and appropriate therapies can begin," he added.

It consists of a mobile app for caregivers to answer questions about behavioural problems and to upload videos of their child, plus a video analysis portal that allows specialists to view and analyse those videos.

It also includes a healthcare provider portal  that can be used to enter answers to questions about behaviour, track information provided by caregivers, and review results.

Canvas Dx has been approved by the FDA to diagnose children aged between 18 months and five years, based on a pivotal study published last autumn involving 425 children aged with concerns about their development, but with no formal assessment for autism.

The study compared the device's ability to detect ASD by comparing its diagnostic output with the clinical reference standard made by a specialist clinician, and validated by specialist peers.

Cognoa said the results showed the device was highly accurate across males and females as well as ethnic and racial backgrounds, which could address a longstanding issue of disparities in autism diagnoses.

"The current system is already at a breaking point as it is unable to provide early diagnoses and intervention opportunities to many children and families," said Dave Happel, Cognoa's chief executive.

"With rapidly-rising autism rates, this crisis will only worsen without new approaches and innovations."