Cognoa is one step closer in its effort to get the first US Food and Drug Administration-cleared medical device for early diagnosis of autistic spectrum disorder (ASD) to market.
The Palo Alto, CA-based company announced on 23 September it will be submitting its artificial-intelligence-powered digital app for early detection of autism for de novo clearance. If cleared by the FDA, it could potentially shift the standard of care, from waiting months or even years before a child receives a diagnosis of ASD from a doctor, to early intervention during the critical window of a child’s neurodevelopment, Cognoa said. (Also see "Start-Up Spotlight: Cognoa Seeks Breakthrough In Early Diagnosis Of Autism And ADD" - Medtech Insight, 12 Feb, 2019.)
“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, Cognoa’s CEO.
The cohort, double-blinded study, which ran from July 2019 to May 2020, evaluated the ability of Cognoa’s ASD Diagnostic device to aid in the diagnosis of ASD by comparing it to the standard of care, which is a clinician’s appraisal of ASD symptoms based on the DSM-5 criteria, the standard classification of mental disorders. The study enrolled 425 participants ages 18 to 72 months, whose caregivers or pediatricians had expressed concern about the child’s development, but were not evaluated or diagnosed with the neurodevelopmental disorder.
Cognoa said the study findings showed that the ASD Diagnostic app performed equally well when administered remotely. The study also showed that the device is highly accurate across genders and ethnic and racial backgrounds. The results are being prepared for publication in a peer-reviewed journal, according to the company.
“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 one in every 54 children with ASD and ensure that these children receive access to the appropriate care and treatment.” – Colleen Kraft
If cleared by the FDA, the device would help about 64,000 general pediatricians across the US rule out or diagnose autism, Cognoa said. (Also see "The Top 5 Start-Up Spotlight Stories In 2019: Two Pore Guys, Distalmotion, SetPoint, Innovative Cardiovascular Solutions, Cognoa" - Medtech Insight, 6 Jan, 2020.)
According to an article on the clinical impact of early diagnosis of autism, published in 2017 in Psychology Research and Behavior Management, lead author Jennifer Harrison Elder wrote “ASD has an unclear etiology and no known cure, making it difficult to acquire accurate and timely diagnoses.” The researcher noted that early diagnosis and treatment can significantly improve the life of a child with ASD and their family.
“There is a significant unmet need for early ASD diagnosis in the pediatric primary care setting,” said Colleen Kraft, former president of the American Academy of Pediatrics 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 one in every 54 children with ASD and ensure that these children receive access to the appropriate care and treatment.”
The FDA granted Cognoa’s device breakthrough designation in February of 2019. The FDA reserves the de novo pathway for novel devices that do not pose a significant risk but aren’t eligible for 510(k) review because the intended use or technology raises new safety and efficacy concerns. (Also see "FDA Gives Insight On Changing Approval Landscape" - Medtech Insight, 16 Sep, 2020.)