Cognoa's AI-powered diagnostic app for autism clears clinical study, heads for FDA review

Cognoa app
Cognoa offers a separate mobile screening app through partnerships with therapy providers, designed to support the growth of a child's motor, social and emotional skills. (Cognoa)

Cognoa aims to equip primary care pediatricians with an artificial-intelligence-powered digital app that can spot the signs of autism, allowing them to rule out or diagnose spectrum disorders within the doctor’s office or remotely.

This could represent a broad shift in the standard of care, as most children are referred to specialists for diagnosis and later treatment—a process that can take years—and could allow for earlier interventions during critical windows in a child’s neurodevelopment. 

Cognoa recently completed a clinical trial of 425 children between the ages of 1 1/2 and 6, comparing the company’s diagnostic program to the clinical standards performed by specialists based on DSM-5 criteria.

The mobile app gathers input from parents, caregivers and healthcare providers through questionnaires and can upload video of children interacting with others or performing tasks before delivering the result as a diagnostic aid to the physician. According to the company, the study showed the program can be highly accurate across genders as well as ethnic and racial backgrounds.

"There is a significant unmet need for early ASD diagnosis in the pediatric primary care setting," said Colleen Kraft, Cognoa’s senior medical director of clinical adoption. "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,” added Kraft, who previously served as president of the American Academy of Pediatrics.

RELATED: Cognoa teams up with Autism Learning Partners to distribute its smartphone screening app

The diagnostic was previously granted a breakthrough designation by the FDA in 2018, and Cognoa said it plans to submit the device to the agency for review in the near future. The study’s results are planned for publication in an upcoming peer-reviewed journal. 

“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,” Cognoa CEO David Happel said. “The accuracy of our autism diagnostic solution is unparalleled, exceeding all pre-specified endpoints, and we are looking forward to a priority review.”

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