Pediatric behavioural health company Cognoa has announced that its pivotal study of digital autism diagnostic device has met all Food and Drug Administration (FDA) targets.
The study evaluated the autism spectrum disorder (ASD) diagnostic in 425 participants aged between 18 to 72 months. It also evaluated the device ability to assist in the diagnosis of ASD by comparing its diagnostic output with the clinical reference standard.
ASD diagnostic received breakthrough device designation from FDA in 2018. It will be submitted to the agency for clearance.
Cognoa develops diagnostic and therapeutic solutions for children living with autism and other behavioural health conditions. The company plans to launch a method for diagnosing ASD in the primary care setting with the help of artificial intelligence.
Currently, children with suspected developmental delay are referred by paediatricians to specialists to diagnose and prescribe treatment. This often forces families to wait months or even years before their child receives an initial diagnosis of ASD and can start therapy, the company noted.
Cognoa added that it has developed the solution to transform the standard of care by reducing the time required for diagnosis and enabling early intervention to begin during critical neurodevelopmental windows.
Early intervention has shown to improve lifelong outcomes for children and their families living with autism.
Cognoa CEO David Happel said: “The data from our pivotal study was strong, and we are incredibly excited to submit a De Novo request for FDA clearance of Cognoa’s ASD Diagnostic.
“The accuracy of our autism diagnostic solution is unparalleled, exceeding all pre-specified endpoints, and we are looking forward to a priority review. Cognoa’s mission is to improve the lives of children and families living with autism and helping paediatricians diagnose autism within the primary care setting is a vital first step.”
Cognoa’s ASD diagnostic, if cleared by the FDA, is expected to help approximately 64,000 general paediatricians across the US to diagnose autism and facilitate early intervention for children with ASD.
Cognoa Clinical Adoption senior medical director Dr Colleen Kraft said: “A clinically validated, FDA-cleared digital assessment platform would empower paediatricians to take definitive action on parental concerns.
“They would be able to diagnose ASD much more efficiently with actionable information to drive the clinical management of the one in every 54 children with ASD and ensure that these children receive access to the appropriate care and treatment.”