Cognoa, a Palo Alto-based pediatric behavioral health startup, recently received U.S. Food and Drug Administration marketing authorization for its first-of-its-kind autism diagnosis aid, Canvas Dx.

The artificial-intelligence-based Canvas Dx is designed to help primary-care physicians diagnose autism in young children with the goals of shortening diagnosis times and enabling earlier intervention. Canvas Dx evaluates both caregiver information completed at home via an app and physician inputs, and if the information is sufficient, generates a result the physician uses as an aid to diagnose or rule out autism and direct appropriate next steps in care.

From the time of parental or physician initial concern to diagnosis, Canvas Dx helps facilitate a diagnosis in a few weeks – not months or years, as is standard in today’s diagnostic processes. With its AI algorithm trained using diverse data sets in terms of race, gender, educational level and socioeconomic status, Canvas Dx has the potential to help primary-care physicians avoid biases and disparities existing in the current autism diagnostic process.

Disparities in diagnosis

Autism is an increasingly common neurodevelopmental condition that today affects one in every 54 children in the U.S., a 178% increase in prevalence since 2000, according to research published by the U.S. Centers for Disease Control and Prevention. While autism can be reliably diagnosed in children as early as 18 months, the average age of autism diagnosis has remained at 4 to 5 years old for decades. Nonwhite children, females and those from rural areas or disadvantaged socioeconomic backgrounds are often diagnosed even later, or missed altogether.

This means many children miss a critical neurodevelopmental window when early diagnosis and subsequent early interventions have the greatest potential to improve lifelong outcomes. Research shows that disparities in autism diagnosis are largely due to the lack of female and diverse representation in autism research to date. In addition, studies reveal that the reliance on diagnostic assessments that are time-consuming to administer within the specialty care setting and the growing shortage of diagnostic specialists contribute to theaverage three-year delay between first concern and diagnosis.

“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,” said Dave Happel, CEO of Cognoa. “With rapidly rising autism rates, this crisis will only worsen without new approaches and innovations. The FDA authorization of our diagnosis aid, Canvas Dx, is a significant milestone in Cognoa’s development and a crucial step towards making early diagnoses more accessible to children and families – regardless of gender, ethnicity, race, ZIP code or socioeconomic background. We look forward to partnering with the health-care community as we introduce Canvas Dx in the coming months.”

Dr. Colleen Kraft, former American Academy of Pediatrics president and current senior medical director of clinical adoption at Cognoa, said primary-care physicians are uniquely positioned to identify developmental delay and behavioral conditions.

“Many are already managing children with behavioral health conditions such as ADHD, anxiety and depression,” Kraft said. “Canvas Dx will provide primary-care physicians actionable information to better understand their patients’ neurodevelopmental picture, allowing pediatricians, who are frequently the primary point of contact for families, to respond to early developmental concerns.”

The FDA granted Canvas Dx authorization following a study in which the device exceeded endpoints. Cognoa expects to make Canvas Dx available in the U.S. later in 2021.

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