Cognoa targets De Novo authorization for its autism diagnostic after reporting strong pivotal study results

The company said that its tool was "highly accurate" in a 425-participant study conducted across 14 U.S. sites.
By Dave Muoio
09:45 am

Cognoa, a digital health company developing software tools for children with autism and other behavioral health conditions and their families, signaled today that it will be moving ahead with a De Novo FDA regulatory submission for its digital autism spectrum disorder (ASD) diagnostic.

The tool, which received a Breakthrough Device Designation from the agency in late 2018, is designed to help primary care clinicians and pediatricians evaluate and diagnose suspected cases of autism among children without the need for a behavioral health specialist. It does so using machine learning and predictive analytics to combine input from providers, parents and uploaded videos of the child's behavior.

The decision to move forward was driven by findings from Cognoa's pivotal trial of the diagnostic, which the company said surpassed all of the FDA's targets.

Conducted between July 2019 and May 2020, the prospective, double-blinded, active comparator cohort study ran across 14 U.S. sites and involved 425 children aged 18 months to 72 months who had suspected developmental concerns, but no formal ASD diagnosis. It measured the tool's ability to correctly spot positive cases and rule out negatives against diagnoses made by a specialist clinician following standard criteria.

"At this time, as we prepare to file for FDA submission, we are not able to share the exact findings of the study," Cognoa CEO David Happel told MobiHealthNews in an email statement. "However, I'd like to emphasize that we surpassed all predetermined endpoints, and we are preparing to submit the study results for publication in a peer-reviewed journal in the coming months. The significance of the results is that the study proved that the device is highly accurate and enables pediatricians to effectively diagnose autism in the primary care setting."

Cognoa noted in its announcement that the study also included primary care appointments conducted via telemedicine, and that the diagnostic software also performed well when used remotely. 


Early identification of ASD is the first step toward prompt intervention and connection to supporting therapies for families and caretakers. Cognoa's software would cut down the time it takes for a family to receive a referral and specialist appointment, and due to its scalable nature could be easily provided to pediatricians across the country.

"There is a significant unmet need for early ASD diagnosis in the pediatric primary care setting," Dr. Colleen Kraft, senior medical director of clinical adoption at Cognoa and formerly the president of the American Academy of Pediatrics, said in a statement. "A clinically validated, FDA-cleared digital assessment platform would empower pediatricians to take definitive action on parental concerns. They would be able to diagnose ASD much more efficiently, with actionable information to drive the clinical management of the one in every 54 children with ASD and ensure that these children receive access to the appropriate care and treatment.” 

Of note, Cognoa's diagnostic would exist alongside its digital therapeutic and development-monitoring tools, which are designed for use in the home by families and caretakers.


Cognoa announced the launch of its pivotal trial in October of 2019, and over the years has amassed supporting data and partner rollouts for its development tracking app. Last year the company also licensed a Google Glass-based artificial intelligence system designed to improve social skills in children with ASD from Stanford medicine.

But the digital health and digital therapeutics spaces have been active enough in the developmental health space even without Cognoa's contributions. Just a couple months ago Magellan Health announced that it would be piloting Boston Children's Hospital spin-out Mightier's video game-based platform that aims to help children regulate their emotions.

This was around the same time as a $10 million funding announcement from Sprout, an autism care and treatment program for families that relies heavily on digital technologies. And stepping outside of autism, Akili's high-profile digital therapeutic for treatment of pediatric ADHD symptoms recently received its own De Novo authorization from the FDA.


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