FDA approves new tool to aid in diagnosing autism

The FDA recently approved a tool to aid pediatricians in diagnosing autism in the primary care setting. Diagnosing the condition earlier could lead to better treatment.

At 12-months-old, Maryanne DeVivo starting having concerns about her daughter, Adrianna’s, development.

“Adriana was completely nonverbal. She didn’t understand I was Mom and my husband was Dad. And she was very delayed on all her developmental milestones,” DeVivo said.

A specialist diagnosed the toddler weeks later with Autism Spectrum Disorder.

“She set us up with a home program. And I had ABA therapists, speech therapists, occupational therapists, physical therapists, my door was a revolving door,” DeVivo said. “The earlier you get in, the better these children do.”

Dr. Colleen Kraft is the senior medical director of Clinical adoption at Cognoa. “That specialist visit takes anywhere between six and 18 months to be completed. And those kids are losing so much time, what they could be spending in interventions and helping their speech and language and behavior,” said Kraft.

Now, the FDA approved a new tool to speed up the process and get children into therapy faster. The Canvas DX Diagnostic Aid works by having parents answer questions and upload videos of their child through an app. Then, experts review the material and the child’s pediatrician weighs in.

425 children were evaluated using this software. The device accurately diagnosed Autism Spectrum Disorder in 98.4% of children with the condition.

“We can now begin to figure out what’s going on and identify which kids need to be in therapies now, and which kids really do need that long-term specialty involvement and diagnosis,” said Dr. Kraft.

Kraft is part of the team behind The Canvas DX. She says that the software also addresses the shortage of specialists.

“This would certainly be something that we would be able to use in areas where we don’t have developmental-behavioral pediatricians or neurologists or psychiatrists,” said Dr. Kraft.

DeVivo says that Adrianna’s early diagnosis and interventions changed her life.

“She has language now, she reads, she does math. She is doing data entry for Family Initiative on Thursdays, so she’s got a little job,” DeVivo said.

This is something she wants for all families.

The program should hit the market by the end of 2021. And, developers expect it to be available by prescription and paid for by insurance. But, you don’t have to wait until then.

Free early detection screenings are available in Southwest Florida this month.