The FDA has cleared a device to help healthcare providers diagnose children with autism. (FDA / Flickr)
Federal regulators have authorized a one-of-a-kind device to help primary care physicians determine whether a child has autism or not, potentially allowing children to be diagnosed much earlier by avoiding long waits for specialists.
The Food and Drug Administration gave the green light to market the Cognoa ASD diagnostic aid this month, which will be dubbed Canvas Dx.
The machine learning-based software uses an algorithm to analyze data submitted by parents and healthcare providers to return a “positive for ASD” or “negative for ASD” response for a child.
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To use the device, parents and caregivers answer behavioral questions and submit videos of the child through a mobile app while the healthcare provider answers questions through a special portal. The videos are reviewed by certified specialists and the algorithm makes a decision as long as there is enough information provided.
It is the first device cleared by the FDA to help primary care physicians diagnose autism, according to Cognoa, which manufactures the product.
Since the symptoms of autism vary, the disease can be difficult to diagnose, the FDA said. As a result, the latest data from the Centers for Disease Control and Prevention shows the median age for autism diagnosis to be over 4 years old, although intellectual disability can be reliably detected at age 2. . Part of the problem is that families often experience long waits to see a clinician qualified to assess children with autism.
Cognoa’s support aims to help solve this problem by giving primary care physicians with less specialized training the tools to make a diagnosis themselves. This can happen with the device within weeks, the company said, instead of taking months or years, allowing children on the spectrum to start early intervention earlier.
“Autism spectrum disorders can delay a child’s physical, cognitive and social development, including the development of motor skills, learning, communication and interaction with others. The earlier ASD can be diagnosed, the sooner 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 to help diagnose children with ASD.”
In a Cognoa ASD diagnostic aid study of 425 children aged 18 months to 5 years, the device gave a result for about one-third of the children. Of those who were “positive for ASD,” a panel of clinical experts found that 81% were on the spectrum. The clinical panel agreed with the aid results in 98% of the children who tested “negative for ASD.”
The FDA has approved the device for use with children between the ages of 18 months and 5 years who are considered to be at risk for developmental delay due to concerns raised by their parents, caregivers, or health care providers. 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 has indicated that they plan to start making Canvas Dx available later this year.
“Primary care physicians are uniquely placed to identify developmental delays and behavioral problems. Many are already managing children with behavioral health problems such as ADHD, anxiety and depression, ”said Dr. Colleen Kraft, senior medical director of clinical adoption at Cognoa and past president of the American Academy of. Pediatrics. “Canvas Dx will provide primary care physicians with actionable information to better understand the neurodevelopmental picture of their patients, enabling pediatricians, who are often the primary point of contact for families, to respond to early development issues. “