Cognoa Launches Pivotal Study of the First Digital Diagnostic for AutismPivotal Study Results Will be Basis of a Premarket Submission to FDA
Palo Alto, Calif., Oct. 24, 2019 (GLOBE NEWSWIRE) -- Cognoa, a company at the forefront of pediatric behavioral health, announced today initiation of its Pivotal Study to demonstrate the effectiveness of its diagnostic aid for autism spectrum disorder (ASD). The company anticipates submitting the results of this multi-site, prospective, blinded, active comparator study to the U.S. Food and Drug Administration (FDA) in 2020. The Cognoa digital diagnostic has the potential to become the first cleared medical device to help diagnose autism. It 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.
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. Cognoa has received FDA Breakthrough Device designation for its two lead products, the first digital diagnostic for autism and a digital therapeutic to treat autism. This designation provides priority review for clearance by the FDA.
“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.”
“The current system does not serve children with autism or families who are concerned about their child’s development. Barriers to treatment will not change as long as access to diagnosis and treatment stays heavily reliant on specialty care, where we face a growing shortfall. We believe digital medicines can help address the limitations of our current system, making both primary and specialty care physicians more efficient and effective,” said Dr. Sharief Taraman, Chief Medical Officer of Cognoa, Division Chief at CHOC Children’s and Vice President of the American Academy of Pediatrics Orange County, California Chapter.
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.
About Cognoa, Inc.
Cognoa is a leading pediatric behavioral health company. We are developing prescription digital therapeutics and medicines for the earlier identification and treatment of behavioral health conditions in order to change the standard of care and improve lifelong outcomes for children. Our lead products, the first digital diagnostic aid and the first prescription digital therapeutic for autism, have both received Breakthrough Device designation from the FDA. Additional products in Cognoa’s pipeline address other pediatric behavioral health indications including ADHD and anxiety. Available today through employers, health plans and treatment providers, the Cognoa for Child Development app has been used by more than 250,000 parents to assess, track and support their child’s developmental health. For more information, visit www.cognoa.com.
Helen Shik Cognoa 617-510-4373 firstname.lastname@example.org