Cognoa's AI app for diagnosing childhood autism gets FDA green light

In a first for the use of artificial intelligence in healthcare, the FDA has given a green light to a program designed to help primary care doctors diagnose autism in children at an early age, potentially when interventions may have the greatest effect on their neurodevelopment.

Cognoa’s Canvas Dx app takes in questionnaires filled out by caregivers and information from physicians as well as video of a child interacting with others or performing tasks, before providing assistance in making a diagnosis for autism spectrum disorder either within the doctor’s office or remotely.

Intended for children between the ages of 18 months and five years, the machine learning software aims to help make clinical decisions faster than previous methods—which may require referrals to a specialist plus a difficult process that can take years to identify varying symptoms.

According to the FDA, though autism spectrum disorder affects about 1 in 54 children, and signs may first become apparent as early as 18 months, the average age at diagnosis may be closer to four-and-a-half years old.

In addition, nonwhite children, females and people from rural areas or disadvantaged socioeconomic backgrounds are often diagnosed later or missed altogether, according to Cognoa.

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“Autism spectrum disorder can delay a child’s physical, cognitive and social development, including motor skill development, learning, communication and interacting with others,” said Jeff Shuren, M.D., the FDA’s device center director. “The earlier [autism spectrum disorder] can be diagnosed, the more quickly intervention strategies and appropriate therapies can begin.”

Last year, Cognoa said it successfully completed a clinical trial of 425 children between the ages of 18 months and six years, comparing the accuracy of the company’s diagnostic program to a panel of specialists and clinical standards based on DSM-5 criteria.

The app was able to provide a diagnosis for 32% of the study’s participants, with those results matching the panel’s conclusions 81% of the time for those who tested positive and 98% for those who tested negative, according to the FDA, which granted a de novo authorization.

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"The current system is already at a breaking point as it is unable to provide early diagnoses and intervention opportunities to many children and families,” Cognoa CEO Dave Happel said in a statement. “With rapidly rising autism rates, this crisis will only worsen without new approaches and innovations." 

Happel said the program could help make diagnoses more accessible regardless of a child’s gender, race or ethnicity and their family’s zip code or socio-economic background. The company said it plans to introduce Canvas Dx through its health system partners in the coming months.