Novel Aid to Help Diagnose Autism Gets FDA Nod

An aid to help healthcare providers diagnose autism spectrum disorder (ASD) in children with potential ASD symptoms earned a nod from the FDA Wednesday.

The Cognoa ASD Diagnosis Aid (Canvas Dx) uses a machine learning algorithm and information from parents or caregivers, video analysts, and healthcare providers to help evaluate patients ages 18 months through 5 years. The device is indicated as an aid in the diagnosis of ASD for children at risk of developmental delay. It is not indicated for use as a stand-alone diagnostic device, but as an adjunct to the diagnostic process.

“The earlier ASD can be diagnosed, the more quickly intervention strategies and appropriate therapies can begin,” said Jeff Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, said in a statement. “Today’s marketing authorization provides a new tool for helping diagnose children with ASD.”

“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, in a statement. “With rapidly-rising autism rates, this crisis will only worsen without new approaches and innovations.”

The ASD diagnosis aid has three main parts: a mobile app for caregivers and parents to answer questions about behavior problems and to upload videos of their child, a portal for specialists to analyze patient videos, and a portal for healthcare providers to answer questions about behavior problems, track information from parents or caregivers, and review results.

If there’s enough information for the algorithm, the aid reports a positive or negative diagnosis. If there’s not enough information, it indicates that no result can be generated.

In a pivotal study of 425 pediatric patients with an average age of almost 3, the ASD Diagnosis Aid matched assessments made by a panel of clinical experts for 81% of patients who tested positive and 98% of patients who tested negative. The device provided a “positive for ASD” or “negative for ASD” result to help diagnose 32% of patients. It also made an accurate determination in 98.4% of patients with ASD and 78.9% of patients without the condition.

Risks associated with the device include misdiagnosis and delayed diagnosis based on false-positive results (seen in 15 of 303 children without ASD) or false-negative results (observed in one of 122 children with ASD), or when no result is generated. Both misdiagnosis or missed diagnosis can result in delayed treatment of ASD and delivery of treatment not appropriate for ASD, the FDA cautioned.

The FDA reviewed the ASD Diagnosis Aid through the De Novo premarket review pathway for low- to moderate-risk devices of a new type. Cognoa plans to start making Canvas Dx available in the U.S. later in 2021.