Start-Up Spotlight: Cognoa Seeks Breakthrough In Early Diagnosis Of Autism And ADD
US FDA recently granted Cognoa’s autism diagnostic device a Breakthrough Device designation to accelerate its efforts to get the first FDA-cleared medical device for the early diagnosis of autistic spectrum disorder (ASD) to market. The average age of ASD diagnosis is about four years old, but extensive clinical research has shown that earlier diagnosis of ASD can improve outcomes over the child’s lifetime. Cognoa’s system is intended to allow primary care physicians to diagnosis ASD in the children as young as 18 months.
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FDA clearance of the ASD Diagnostic app could lead to early diagnosis, improving quality of life of children with ASD and their caregivers.
US FDA issued a final guidance that sets out requirements for its new Breakthrough Devices Program mandated by Congress. Under the new program, which replaces the Expedited Access Pathway, sponsors have more certainty about how quickly they will get responses from the agency and fewer requirements when setting up early interactions.
The company’s revenue was down just 1% year-over-year in the third quarter of fiscal 2021, despite the ongoing impact of the pandemic.