Cognoa has secured approval from the US Food and Drug Administration (FDA) for its diagnostic device for autism spectrum disorder (ASD).
The Cognoa ASD Diagnosis Aid is a machine learning-based software, which will enable health care providers to diagnose ASD in children 18 months through five years of age who show potential symptoms of the disorder.
The Centers for Disease Control and Prevention describes ASD as a developmental disability that can cause significant social, communication and behavioural challenges.
FDA’s Center for Devices and Radiological Health director Dr Jeff Shuren said: “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.”
Cognoa’s software as a medical device uses a machine-learning algorithm to secure input from parents or caregivers, video analysts and health care providers to support physicians assess a patient at risk of ASD.
The device includes three main components, comprising a mobile app for caregivers and parents to answer questions regarding behaviour problems and to upload videos of their child.
The video analysis portal is a second component that enables manufacturer-trained and certified specialists to view and analyse uploaded videos of patients.
In addition, the third component is a health care provider portal that will help health care providers to enter answers to pre-loaded questions about behaviour problems, track the information provided by parents or caregivers and review a report of the results.
The ASD Diagnosis Aid processes the information delivered by parents, caregivers and healthcare providers and reports a positive or negative diagnosis if there is sufficient information for its algorithm to make a diagnosis.
The FDA evaluated the safety and efficacy of the Cognoa ASD Diagnosis Aid in a 452-patient study aged 18 months through five years in 14 different clinical care sites, with an average age of 2.8 years.
According to the FDA, the device offered a positive for ASD or negative for ASD result to assist in making a diagnosis in 32% of patients.
