U.S. FDA today authorized Cognoa’s machine learning-based software to help diagnose autism spectrum disorder.
The de novo authorization from FDA covers the use of the Cognoa ASD Diagnosis Aid with children 18 months through 5 years of age with potential ASD symptoms. Palo Alto, Calif.–based Cognoa has touted the software as a way to do away with the time delays parents can experience as they try to schedule their children with specialists after a referral from a pediatrician.
“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,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a news release.
The Cognoa ASD Diagnosis Aid uses a machine-learning algorithm to receive input from parents or caregivers, video analysts and health care providers to help evaluate the risk of ASD.
The product includes a mobile app for caregivers and parents to answer questions about behavior problems and to upload videos of their children. There’s a video analysis portal that allows manufacturer-trained and certified specialists to view and analyze uploaded videos of patients. A health care provider over a portal can enter answers to pre-loaded questions about behavior problems, track information, and review results.
The ASD Diagnosis Aid reports a positive or negative diagnosis if there is sufficient information for its algorithm to make a diagnosis. If there is insufficient information, the ASD Diagnosis Aid will report that there’s no result.
The FDA decision came after a study of 425 patients aged 18 months through 5 years at 14 different clinical care sites. The study compared ASD Diagnosis Aid assessments against a clinical expert panel’s assessments. The software provided a positive or negative ASK result for nearly a third of patients, matching the panel’s conclusions for 81% of patients who tested positive for ASD on the diagnostic aid and 98% of patients who tested negative.