June 03, 2021 -- The FDA has approved marketing for a device that will help diagnose autism spectrum disorder in children between the ages of 18 months and 5 years who show potential symptoms.

Cognoa ASD Diagnosis Aid is a machine learning–based software program that receives information from parents or caregivers, video analysts, and health care providers to help doctors evaluate whether a child is at risk of having autism.

Autism is a developmental disorder that can cause social, communication, and behavioral challenges. It affects about 1 in 54 children. It is difficult to diagnose because there isn't a medical test to diagnose it. Instead, doctors have to look at a child's developmental history and behavior to make a diagnosis.

Many children are not diagnosed with autism disorders until later in childhood, which in some cases delays treatment and early intervention. Autism may be detected as early as 18 months, but the average age of diagnosis is 4.3 years, according to the FDA.

"The earlier ASD can be diagnosed, the more quickly intervention strategies and appropriate therapies can begin," Jeff Shuren, MD, director of the 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 safety and efficacy of the Cognoa ASD Diagnosis Aid was tested in a study of 425 patients. For the study, researchers compared the diagnostic assessments made by the device to those made by a panel of clinical experts who used the current standard process to diagnose autism spectrum disorders.

The device diagnosed 32% of the children with either a positive or a negative result. Researchers found that the device matched the panel's conclusions for 81% of the patients who received a positive diagnosis. For those who received a negative diagnosis, the device matched the panel's conclusions for 98% of the patients. In addition, the device made an accurate determination in 98.4% of patients with the condition and in 78.9% of patients without the condition.

Cognoa ASD Diagnosis Aid has three main components. One includes a mobile app for caregivers to answer questions about the child's behavioral problems and to upload videos of the child. The next component is a video analysis portal for specialists to view and analyze the videos. Another is a portal for health care providers that allows them to enter answers to preloaded questions about behavior problems, track the information provided by parents, and review a report of the results.

Researchers said a false-positive result occurred in 15 out of 303 study subjects without ASD and a false-negative result occurred in 1 out of 122 study subjects with ASD.

The FDA emphasized that the device is only designed to help doctors diagnose autism in children. It isn’t designed to diagnose children on its own.