– Cognoa launches a pivotal study to demonstrate the effectiveness of its diagnostic aid for autism spectrum disorder (ASD).
– The results of this pivotal study will be the basis for the submission to the FDA in 2020.
– The Cognoa digital diagnostic aid has the potential to become the first cleared medical device to help diagnose autism intended to be used by pediatricians and primary care physicians.
Cognoa, a Palo Alto, CA-based pediatric behavioral health company developing digital medicines, announced the launch of a pivotal study of its digital diagnostic aid for autism. The results of this pivotal study will be the basis for the submission to FDA next year.
Study of Diagnostic Aid for Autism
Cognoa is developing AI-powered digital therapeutics and medicines to advance the standard of care in pediatric behavioral health and improve lifelong outcomes for children. The study is intended to enable pediatricians and physicians in primary care settings to make an autism diagnosis in children as young as 18 months, so that children can receive earlier treatment.
Currently, children are diagnosed for autism by a specialist at an average age of 4 years 4 months, which is after the primary window of brain development when interventions can have the greatest impact. The Cognoa digital diagnostic aid has the potential to become the first cleared medical device to help diagnose autism intended to be used by pediatricians and primary care physicians.
Cognoa is the only digital therapeutics company with two Breakthrough device designations from the FDA for its digital diagnostic aid and a digital therapeutic for autism. The study launch comes soon after the announcement that Cognoa is well underway with plans for commercialization in 2020. Last month, Cognoa announced a partnership with EVERSANA that will enable Cognoa’s digital therapeutics and medicines to be prescribed, dispensed and reimbursed through the existing healthcare infrastructure utilized by medical devices and pharma.
Recent Published Research Studies
Recent published studies reinforce the current crisis in access to timely autism diagnosis and care. In September, a study published in Pediatrics found that the most commonly used screener by pediatricians, the M-CHAT, was less effective in identifying autism than previously reported. Another study found that more than two-thirds of children flagged for autism were not referred to a specialist for treatment. In published studies, prior versions of Cognoa’s algorithm have been clinically validated to screen for autism as early as 18 months of age. Results demonstrate continuous improvements and higher accuracy compared to other behavioral health screening tools including the Revised M-CHAT.
Why It Matters
“Cognoa believes digital therapeutics can fundamentally improve the standard of care for pediatric behavioral health. Our breakthrough products will empower both parents and their trusted family physicians so that every child can receive an earlier diagnosis and treatment when there is the greatest ability to impact the child’s development and improve lifelong outcomes,” said Brent Vaughan, CEO of Cognoa. “Building upon Cognoa’s previous successful clinical studies, this pivotal study is an important milestone for our company. In tandem, we have established our commercial model with our partner, EVERSANA, that will enable access to our digital therapeutics by physicians through existing prescription, distribution and reimbursement infrastructures for utmost efficiency.”