Cognoa Launches Pivotal Study of Digital Diagnostic of Autism for Premarket FDA Submission

Cognoa digital diagnosis of autism
Image credit: 433rd Airlift Wing

Cognoa, a Palo Alto, CA-based consumer healthcare company for pediatric behavioral health, announced the initiation of its Pivotal Study to demonstrate the effectiveness of its diagnostic aid for autism spectrum disorder (ASD). The company anticipates submitting the results of this multi-site, prospective, blinded, active comparator study to the U.S. Food and Drug Administration (FDA) in 2020. The Cognoa digital diagnostic has the potential to become the first cleared medical device to help diagnose autism.

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“Cognoa believes digital therapeutics can fundamentally improve the standard of care for pediatric behavioral health. Our breakthrough products will empower both parents and their trusted family physicians so that every child can receive an earlier diagnosis and treatment when there is the greatest ability to impact the child’s development and improve lifelong outcomes,” said Brent Vaughan, CEO of Cognoa. “Building upon Cognoa’s previous successful clinical studies, this pivotal study is an important milestone for our company. In tandem, we have established our commercial model with our partner, EVERSANA, that will enable access to our digital therapeutics by physicians through existing prescription, distribution and reimbursement infrastructures for utmost efficiency.”

Mother and child
Image: Cognoa (Linkedin)

Current method of autism diagnosis pinpoints autism when the child is of 4 years and 4 months of age, which is after the primary window of brain development when interventions can have the greatest impact. Cognoa’s AI-powered digital therapeutics is intended to enable pediatricians and physicians in primary care settings to make an autism diagnosis in children as young as 18 months, so that children can receive earlier treatment, says a press release.

Cognoa has received FDA Breakthrough Device designation for its two lead products, the first digital diagnostic for autism and a digital therapeutic to treat autism. This designation provides priority review for clearance by the FDA.

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“The current system does not serve children with autism or families who are concerned about their child’s development. Barriers to treatment will not change as long as access to diagnosis and treatment stays heavily reliant on specialty care, where we face a growing shortfall. We believe digital medicines can help address the limitations of our current system, making both primary and specialty care physicians more efficient and effective,” said Dr. Sharief Taraman, Chief Medical Officer of Cognoa, Division Chief at CHOC Children’s and Vice President of the American Academy of Pediatrics Orange County, California Chapter.