On June 7, 2021 federal regulators authorized a first-of-its-kind device to help primary care doctors determine whether or not a child has Autism Spectrum Disorder (ASD), potentially allowing kids to be diagnosed far sooner by avoiding lengthy waits for specialists.
The Food and Drug Administration (FDA) gave the green light to market the Cognoa Autism Spectrum Disorder Diagnosis Aid. The machine learning-based software uses an algorithm to analyze data submitted by parents and health care providers in order to return a “positive for ASD” or “negative for ASD” response for a child.
The FDA has approved the device for use with children ages 18 months through 5 years who are considered to be at risk of developmental delay due to concerns raised by their parent, caregiver or health care provider. It is not meant to be a stand-alone diagnostic device, but should be used in addition to the traditional diagnostic process, regulators said. Cognoa indicated that it expects to start making Canvas Dx available later this year
To use the device, parents and caregivers answer questions about behavior and submit videos of the child through a mobile app while the health care provider answers questions through a special portal, according to The Cognoa ASD Diagnosis Aid. The videos are reviewed by certified specialists and the algorithm makes a determination so long as there is sufficient information provided. According to Cognoa, this is the first device authorized by the FDA to help primary care physicians diagnose autism.
As it is a spectrum and symptoms can change, ASD can be difficult to diagnose. As a result, the latest data from the Centers for Disease Control and Prevention shows that the median age for ASD is older than 4 even though ASD can be reliably detected by age 2.
The Cognoa aid is intended to help solve that problem by giving primary care physicians with less specialized training the tools to make a diagnosis themselves, that can happen with the device within a few weeks. As opposed to taking months or years, allowing children who are potentially on the spectrum to start early intervention sooner.
“Autism spectrum disorder can delay a child’s physical, cognitive and social development, including motor skill development, learning, communication and interacting with others. The earlier ASD can be diagnosed, the more quickly intervention strategies and appropriate therapies can begin,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health“Today’s marketing authorization provides a new tool for helping diagnose children with ASD.”
The Cognoa ASD Diagnosis Aid involved 425 children ages 18 months to 5 years and returned a result for about a third of the kids. Of those who were positive for ASD, a panel of clinical experts found that 81% were on the spectrum.
“Primary care physicians are uniquely positioned to identify developmental delay and behavioral conditions. Many are already managing children with behavioral health conditions such as ADHD, anxiety and depression,” said Dr. Colleen Kraft , senior medical director of clinical adoption at Cognoa and a former president of the American Academy of Pediatrics .
“This will provide primary care physicians actionable information to better understand their patients’ neurodevelopmental picture, allowing pediatricians, who are frequently the primary point of contact for families, to respond to early developmental concerns.”