A tool that helps pediatricians diagnose autism with artificial intelligence and smartphone video passed a key FDA test and could hit the market as soon as next summer, according to device-maker Cognoa, which recently announced its plans to submit the tool for final approval.

In a trial to measure its safety and effectiveness, doctors diagnosing with the Cognoa tool made the same decision as an expert panel more than enough times to beat its FDA benchmarks, said CEO Dave Happel. He expects the device, which Cognoa says will be the first of its kind, to be approved in the second half of 2021.

If approved, Cognoa could offer a faster path to diagnosis. Parents notice signs of autism at an average of 14 months, but it takes three years for the median child to get diagnosed at 51 months. One reason for the gap is the wait to see a specialist, which can take months to more than a year.

In contrast, Cognoa’s process can provide a diagnosis as soon as two to six weeks after a pediatrician suspects autism and orders the diagnostic, said Happel. That means children could get treatment earlier while their brain is more easily rewired, he said.

Cognoa’s AI works by processing the data of three questionnaires: from the pediatrician, the parents, and an autism specialist who watches two short videos of the child filmed by parents in the Cognoa app. Then the pediatrician receives a result from the AI program, which they use to make a diagnosis.

Currently there is no way to verify the tool’s claims of effectiveness. “Cognoa is not sharing the study data until after we have completed our submission to the FDA,” the company said in an emailed statement, though it will be published in a peer-reviewed journal “in the coming months.” The FDA cannot verify or comment on product applications, said agency spokeswoman Stephanie Caccomo in an email. The agency granted Cognoa Breakthrough Device designation status in 2019, which is a program to speed up development if the device is more effective in treating or diagnosing “life-threatening or irreversibly debilitating human disease or conditions.”

Part of autism business boom

Cognoa, which has raised $60 million since its founding in 2013, is part of a broader infusion of capital into companies for autism products and services. That growth has been fueled by an increase in the number of children being diagnosed with autism and the passage of laws, in all 50 states, that require insurance companies to cover autism services, said Ronit Molko, a consultant to private equity on investments in behavioral health companies and cofounder of the Autism Investor Summit. In the past five years, said Molko, there have been more than 100 deals involving autism-related companies, including the $400 million purchase of an autism therapy provider. “It’s kind of like a feeding frenzy,” she said.

A 2017 report by Research and Markets projected that the US market for autism treatment will grow to $2.23 billion by the end of 2021. The majority of autism companies are service providers that teach social, language, and behavioral skills, said Molko, who cofounded one such business, Autism Spectrum Therapies, before selling it in 2014. Companies making diagnostic tools like Cognoa are comparatively rare.

Molko understands the skepticism by some autism clinicians that products like Cognoa could diagnose as effectively as a specialist who observes a child for as many as 12 hours. At the same time, she sees the promise of AI to cut down the waiting time for diagnoses and make them more accurate. That would help children get services sooner, she said. “The impact on life, and the family, and that individual child is huge.”

Insurance companies also see the promise, according to Happel. They are interested in covering Cognoa, he said, because it will be less expensive than the many specialist visits required for a traditional diagnosis. Insurers are also interested in the device’s potential to get children into treatment earlier, which could improve their diagnosis and lower their need for costlier long-term services. Happel also expects Medicaid, which pays for diagnosis and treatment, to cover Cognoa. The company is still working on pricing the product, he said.

‘Not the answer’

Catherine Lord, an autism clinician and professor at UCLA, agrees that a shortage of specialists like herself is behind the long wait for diagnoses. But products like Cognoa’s will not fix the long wait time, said Lord, the creator of a widely-used diagnostic tool, because they do not provide as many details about the child’s condition as a traditional diagnosis.

Without knowing the severity of autism or the presence of mental disorders, such as ADHD, that often accompany autism, parents can’t make informed decisions about their child’s treatment and education, she said. “The label is an important start, but it is not the answer,” said Lord, who regards Cognoa as a screening device. “It might increase knowledge and referrals,” she said, “but this is just going to send more kids to me.”

In an emailed statement responding to Lord, Cognoa said the device “provides pediatricians with the information needed to give a detailed diagnosis of autism … and prescribe specific individual early interventions” based on criteria from the American Psychiatric Association. For more complex treatment, pediatricians can make referrals to “local specialists and therapists who can provide more specific guidance when needed. A diagnosis of autism is often needed for eligibility to these resources.”

To Lord, there is a straightforward solution to cutting wait times and addressing the shortage of providers: Hospitals should hire more specialists to make evaluations, she said. They have not done that, she argued, because the procedures don’t make money. “The hospital pretty much breaks even,” she said — “or loses money.”

Graison Dangor Contributor