Paediatric behavioural health company Cognoa, which develops diagnostic and therapeutic solutions for children living with autism and other behavioural health conditions, will be submitting its autism spectrum disorder (ASD) diagnostic to the FDA for clearance.
Cognoa’s diagnostic was previously granted Breakthrough Device Designation by the FDA in October 2018.
Cognoa seeks to introduce a new, efficient, and accurate approach to diagnosing ASD in the primary care setting, using artificial intelligence to provide a new paradigm of care that empowers paediatricians. Currently, paediatricians refer most children with suspected developmental delay to specialists to diagnose and prescribe treatment. This often results in children and families facing an arduous process, forcing families to wait months or even years before their child receives an initial diagnosis of ASD and can start life-changing therapy. Cognoa’s solution is positioned to fundamentally change this standard of care by reducing wait times to diagnosis, thereby allowing early intervention to begin during critical neurodevelopmental windows. Early intervention has shown to improve lifelong outcomes for children and their families living with autism.
David Happel, CEO of Cognoa, 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.”
If cleared by the FDA, Cognoa’s ASD Diagnostic will be crucial in helping the approximately 64,000 general paediatricians across the U.S. rule-out or diagnose autism – enabling early intervention and supporting improved life-long outcomes for children, in line with the American Academy of Paediatrics (AAP) updated ASD guidelines as of January 2020. This will streamline the autism care journey for children and families, as specialists will now be able to focus on children with more complex diagnoses.
Dr Collen Kraft, former AAP president and senior medical director of clinical adoption at Cognoa, said: "There is a significant unmet need for early ASD diagnosis in the paediatric primary care setting. 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.”
The pivotal study
Cognoa’s ASD Diagnostic surpassed its targeted benchmarks in a trial involving 425 participants - aged between 18 to 72 months – whose caregivers or paediatricians had expressed concern about their development but who were never formally evaluated or diagnosed with autism.
The pivotal study ran from July 2019 through May 2020 and was a multi-site, prospective, double-blinded, active comparator, cohort study conducted at 14 sites across the U.S. The study evaluated the ability of Cognoa’s ASD Diagnostic device to aid in the diagnosis of ASD by comparing its diagnostic output with the clinical reference standard, consisting of a diagnosis made by a specialist clinician, based on DSM-5 criteria and validated by one or more reviewing specialist clinicians. This approach was taken to effectively evaluate the accuracy of Cognoa’s investigational device as measured by how often in the study population it correctly identifies a patient with ASD, and how frequently it correctly determines that a patient does not have ASD.
As part of the study, caregivers provided information about their child’s behaviour by completing a questionnaire and uploading two short videos using Cognoa’s mobile app. Participating children and their caregiver also completed two doctor’s appointments (one with a primary care physician and one with a paediatric specialist). A number of the primary care appointments were completed via telemedicine, with the study finding that the investigational device performed equally well when administered remotely. The trial also showed that Cognoa’s diagnostic device is highly accurate across males and females as well as ethnic and racial backgrounds, thus addressing a longstanding issue of disparities in autism diagnoses.
