Pediatric behavioral health company Cognoa has received FDA De Novo classification for its autism spectrum disorder (ASD) software diagnostic aid, Canvas Dx.

The ASD diagnostic tool is designed to help primary care clinicians and pediatricians evaluate and diagnose suspected cases of autism among children. It uses machine learning algorithms to analyze videos of the child’s behavior and responses to questions uploaded by parents and caregivers to devise a diagnosis.

Canvas Dx is indicated as an aid in the diagnosis of ASD in patients between the ages 18 months and 5 years old who are at risk of developmental delay based on concerns of a parent, caregiver or healthcare provider. It is not intended to be used as a standalone diagnostic device.

“The FDA authorization of our diagnosis aid, Canvas Dx, is a significant milestone in Cognoa’s development and a crucial step towards making early diagnoses more accessible to children and families – regardless of gender, ethnicity, race, zip code, or socioeconomic background,” Dave Happel, CEO of Cognoa, said in a statement. “We look forward to partnering with the healthcare community as we introduce Canvas Dx in the coming months.”

Cognoa received a Breakthrough Device Designation from the agency in 2019 for the tool and achieved the De Novo classification through the FDA’s premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.

The FDA assessed the safety and effectiveness of Canvas Dx based on Cognoa’s pivotal study that compared diagnoses from the device against those made by a panel of clinical experts who used the current standard ASD diagnostic process. The study included 425 patients aged 18 months through 5 years in 14 different clinical care sites, with an average age of 2.8 years.

Canvas Dx’s results matched the panel’s for 81% of patients who tested positive for ASD and 98% of patients who tested negative for ASD. For patients who already had a clinical diagnosis, the device made an accurate ASD determination for 98.4% of patients with it and for 78.9% of patients without it.

WHY THIS MATTERS

ASD is a developmental disability that can affect significant social, communication, emotional and behavioral challenges. The condition is becoming increasingly prevalent in the U.S., and today about one in every 54 children has the disorder, according to the Centers for Disease Control and Prevention.

Because there is no medical test for ASD and because the symptoms can vary from patient to patient, diagnosing the condition can be difficult. Even though it can be detected as early as 18 months, many children don’t receive a diagnosis until they are adolescents or even adults, according to the CDC.

Making matters more difficult, significant diagnostic disparities exist for ASD, according to the Health Resources and Services Administration. Studies show that children with racial or ethnic minority backgrounds, children from disadvantaged socio-economic backgrounds and non-native English speaking children are less likely to be diagnosed with ASD or are diagnosed later than white children.

“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,” Jeff Shuren, MD, J.D., director of the FDA’s Center for Devices and Radiological Health, said in a statement. “Today’s marketing authorization provides a new tool for helping diagnose children with ASD.”

THE LARGER TREND

Cognoa expressed its intention to seek a De Novo classification last fall. Prior to that, the company worked to amass supporting data for its diagnostic tool and leveraged partnerships for real-world evidence. Cognoa also licensed a Google Glass-based artificial intelligence system designed to improve social skills in children with ASD from Stanford medicine.

Other startups with a focus on ASD include Springtide, which last year raised $18.1 million for its multimodal ASD therapy clinic and platform; Sprout, which launched last year with $10 million in seed funding; and Mightier, which has been working with Magellan Health to test a biofeedback video game platform among children with ASD.