Autism Diagnosis Software Gets FDA Authorization

The US Food and Drug Administration has authorized marketing for software designed to help diagnose autism spectrum disorder in young kids. The software, which is called Cognoa ASD Diagnosis Aid, is intended for healthcare providers who have observed possible ASD symptoms in toddlers and young children ages 18 months to 5 years.

Cognoa ASD Diagnosis Aid is a machine learning-based application that includes a mobile app for parents and caregivers, a portal for videos of the child's behavior to be uploaded for analysis, and a portal for healthcare providers to provide information, access data on the patient, and view results.

Assuming enough data is provided for the algorithm to make a diagnosis, the system will return a positive or negative result. The FDA made its authorization based on a study involving 425 patients who had an average age of 2.8 years.

When positive and negative results from the software were compared to diagnoses made by human experts, the study found the software overwhelmingly matched the experts' conclusions about the patients. Of course, there's always the potential for a false positive or negative result, which is why the FDA notes that the Cognoa ASD Diagnosis Aid isn't meant to be a standalone diagnostic device.

In a statement, the FDA's director of Center for Devices and Radiological Health Jeff Shuren, MD, JD, said:

Autism spectrum disorder can delay a child's physical, cognitive and social development, including motor skill development, learning, communication and interacting with others. The earlier ASD can be diagnosed, the more quickly intervention strategies and appropriate therapies can begin. Today's marketing authorization provides a new tool for helping diagnose children with ASD.