Cognoa is vying for FDA clearance of a digital device that has the potential to diagnose autism. Previously, the Palo Alto, CA-based company was granted breakthrough device designation by FDA in 2018.
The firm’s digital precision health platform applies machine learning and predictive analytics to parental inputs and diagnostic data and responses to therapeutics to create more personalized care.
Cognoa pushed forward with the clearance submission after its diagnostic surpassed targeted benchmarks in a pivotal study that ran from July 2019 through May 2020. The trial involved 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 was a double-blinded, active comparator, cohort study conducted at 14 sites across the U.S. 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 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,” David Happel, CEO of Cognoa, said in a release. “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.”