Cognoa Seeks FDA Clearance for Breakthrough Digital Autism Diagnostic Device After Successful Pivotal Study

Cognoa Seeks FDA Clearance for Breakthrough Digital Autism Diagnostic Device After Successful Pivotal Study’s autism diagnostic device is positioned to be the first FDA-cleared digital solution enabling pediatricians to diagnose autism – a paradigm shift in the standard of care

(Palo Alto, Calif. – September 23, 2020) Cognoa, the leading pediatric behavioral health company developing diagnostic and therapeutic solutions for children living with autism and other behavioral health conditions, announced today that after surpassing all FDA targets in the pivotal study, the company 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 pediatricians. Currently, pediatricians 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.    

“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,” said David Happel, CEO of Cognoa. “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 pediatricians  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 pediatricians 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 Pediatrics (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. 

“There is a significant unmet need for early ASD diagnosis in the pediatric primary care setting,” said Dr. Colleen Kraft, former AAP President and Senior Medical Director of Clinical Adoption at Cognoa. “A clinically validated, FDA-cleared digital assessment platform would empower pediatricians 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 1 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 pediatricians 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 behavior by completing a questionnaire and uploading two short videos using Cognoa’s mobile app. In addition, participating children and their caregiver completed two doctor’s appointments (one with a primary care physician and one with a pediatric 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. 

The pivotal study results are being prepared for publication in a peer-reviewed journal.  

About Cognoa

Cognoa is the leading pediatric behavioral health company developing diagnostic and therapeutic solutions that will improve the lives and outcomes of children and families living with behavioral conditions. Cognoa’s products are designed to be routinely prescribed by pediatricians and covered by insurers to improve the standard of care for how children are diagnosed and treated for behavioral health conditions starting with autism. For more information, visit