Federal regulators authorized a first-of-its-kind device to help primary care doctors determine whether or not a child has autism, potentially allowing kids to be diagnosed far sooner by avoiding lengthy waits for specialists.

The Food and Drug Administration gave the green light to market the Cognoa ASD Diagnosis Aid this month, which will be branded Canvas Dx.

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.

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. The videos are reviewed by certified specialists and the algorithm makes a determination so long as there is sufficient information provided.

It is the first device authorized by the FDA to help primary care physicians diagnose autism, according to Cognoa, which makes the product.

Since autism symptoms vary, the condition can be difficult to diagnose, the FDA said. As a result, the latest data from the Centers for Disease Control and Prevention shows that the median age for autism diagnosis is older than 4 even though the developmental disability can be reliably detected by age 2. Part of the problem is that families often encounter long waits in order to see a clinician skilled in evaluating children for autism.

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, the company said, as opposed to taking months or years, allowing children who are 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.”

In a study of the Cognoa ASD Diagnosis Aid that involved 425 children ages 18 months to 5 years, the device 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. The clinical panel agreed with the aid’s findings in 98% of the children who got a “negative for ASD” result.

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.

“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. “Canvas Dx 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.”

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