By Meg Bryant

Children with autism spectrum disorder (ASD) can face a lifetime of frustration because of challenges with communication, social behaviors and flexibility of thought. Early intervention can improve outcomes, but nailing a diagnosis of ASD often takes years. Cognoa Inc. wants to change that with its digital ASD Diagnostic and is on track to apply for U.S. FDA clearance before the end of the year.

“We’re submitting a package for de novo application in the fourth quarter of this year,” David Happel, Cognoa’s CEO, told BioWorld.

The Palo Alto, Calif.-based company snagged an FDA breakthrough device designation for the ASD Diagnostic device in October 2018, paving the way for a priority review. With such reviews averaging eight to nine months, Happel anticipates gaining FDA clearance early in the second half of 2021 and launching the product about eight weeks after that.

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