Pediatric digital therapeutics developer Cognoa has teamed up with Autism Learning Partners, a specialized treatment provider, to put its autism screening app in the hands of parents to help track their children’s development.
Cognoa’s app includes activities designed to support the growth of motor, social and emotional skills, and also help clinicians assess and identify children at risk for autism spectrum disorder, who will then direct them to appropriate diagnostic evaluations and applied behavior analysis, or ABA therapy services.
According to Cognoa, the average age of a child diagnosed with autism is about 4 years and 4 months old, after a window where interventions can be most effective. The company’s app and screening assessment is designed to identify children at risk as young as 18 months old, shortly after the age that early developmental delays are most-often noticed by parents.
“Therapy providers play an essential role in ensuring all children can benefit from early intervention,” Cognoa co-founder and CEO Brent Vaughan said in a statement. “With our partnership, ALP is not only empowering families to better support their children’s developmental health at home, but also helping advance Cognoa’s mission to improve the standard of care in pediatric behavioral health by making early intervention available to every child.”
Cognoa received breakthrough device designations for two other investigational products—a digital autism diagnostic and an app-based therapeutic—from the FDA early last year. Though those two have not yet been approved or cleared by the agency, the company's screening app for children at risk is available through its partnerships with providers and employers.
Cognoa employs machine learning and predictive methods that analyze inputs from parents and other data to guide its digital offerings. In October 2019, the company launched a pivotal study evaluating the effectiveness of its digital diagnostic—it hopes to submit the results of the prospective, blinded, active-comparator trial to the FDA by the end of this year.
Elsewhere, the company is developing diagnostics focused on attention deficit hyperactivity disorder, anxiety and pediatric insomnia. Cognoa has also signed on with the service provider Eversana to sell, distribute and pursue reimbursement for its digital therapeutics in the future.
Editor's Note: This story has been updated to clarify the regulatory status of Cognoa's offerings.