The company aims to release the app and the rest of the Canvas Dx system in the United States by the end of 2021, says Sharief Taraman, Cognoa’s chief medical officer.
In 2018, Cognoa caused confusion among some autism researchers by announcing that the app had been designated an FDA Class II diagnostic medical device, long before the agency made the classification earlier this month.
An algorithm analyzes the data and provides a conclusive ‘yes’ or ‘no’ about whether the child has autism or suggests the child be evaluated for other conditions.
As part of its safety review, the FDA reviewed data from Cognoa’s clinical trial, which compared the app’s evaluation of autism in 425 children, 153 of them girls, with that of a panel of three experts.
The app gave a conclusive result for 135 children, or 32 percent of the group.
The app correctly identified autism in 63 of the 122 autistic children, and 1 autistic child received a false negative.
“Given the performance that Cognoa has published so far, this seems like a potential second-level screening tool.
Much more data on its effectiveness need to be collected before families should shoulder any costs, Goodwin says.