Cognoa Wins FDA Class II Designation for AI-Based Autism Diagnostic

Cognoa said today that its artificial intelligence (AI)-based software platform for behavioral health conditions has received the FDA’s Class II diagnostic medical device designation for autism.

The designation, Cognoa said, will expand its ability to offer its solution to enterprise customers, healthcare payers, and directly to clinicians in primary care settings.

The platform is designed to improve the speed and precision of the diagnosis and treatment of behavioral health conditions by physicians. The company says its diagnostic also offers enterprise companies and healthcare payers an opportunity to offer healthcare benefits for children, while lowering behavioral health treatment costs.

Based on AI technology developed over five years at Harvard and Stanford medical schools, Cognoa’s machine-learning platform is designed to determine the most predictive data to identify risks for behavioral delays, as well as support a diagnosis based upon the child’s natural behavior at home. Using data from the diagnosis, the application recommends personalized, evidence-based activities such as behavioral interventions that parents can carry out at home.

In a study published by Stanford researchers February 12, 2016, in the Journal of Autism and Developmental Disorders, the electronically administered, 7-question autism spectrum disorder (ASD) screen showed 89.9% sensitivity and 79.7% specificity in detecting ASD. “In a high-risk clinical setting, the MARA [Mobile Autism Risk Assessment] shows promise as a screen to distinguish ASD from other developmental/behavioral disorders.”

Cognoa’s platform has been clinically validated to identify autism in children as early as 18 months of age. While ASD can be diagnosed as early as age two years, most children are not diagnosed with ASD until after age four, according to the U.S. Centers for Disease Control and Prevention (CDC).

“We are very encouraged by this FDA determination of Cognoa’s AI-based software as a medical device for diagnosis,” Cognoa co-founder and CEO Brent Vaughan said in a statement. “Cognoa is committed to conducting additional clinical studies and working with both the FDA and clinicians to further validate both our diagnostic software as well as integrated digital therapeutics that will dramatically improve the standard of care for physicians, children, and their families.”

In addition to autism, Cognoa’s platform is also designed to diagnose other conditions related to childhood development, from sleep problems and potty training, to speech delay, and ADHD.