Today, Autism an increasingly common neurodevelopmental condition that today affects one in every 54 children in the U.S, which is a 178% increase in prevalence since 2000.
While Autism can be reliably diagnosed in children as early as 18 months, the average age for an Autism diagnosis has remained at 4 to 5 years for decades. Non-white children, females, and those from rural areas or from disadvantaged socio-economic backgrounds are often diagnosed even later or missed altogether. Disparities in diagnosing Autism are largely due to the lack of female and diverse representation in autism research to date.
In addition, the reliance on time consuming diagnostic assessments required in the specialty care setting and the growing shortage of diagnostic specialists contributes to the average three year delay between the first concern and then the diagnosis.
To meet all the challenges, Cognoa https://www.cognoa.com, a pediatric behavioral health company developing diagnostic and therapeutic solution for children living with behavioral health conditions announced that FDA https://www.fda.gov, has authorized marketing of the Cognoa ASD Diagnosis Aid Device to help diagnose Autism Spectrum Disorder (ASD).
The Cognoa ASD Diagnosis Aid, is intended to help healthcare providers diagnose ASD in a study of 425 patients in children 18 months through 5 years of age who exhibit potential symptoms of the disorder.
The AI-based device is the first FDA authorized diagnosis aid designed to help physicians diagnose autism in the primary care setting. “The current system is unable to provide early diagnoses and intervention opportunities. With the rapidly rising autism rates, this crisis will only worsen without new approaches and innovations,” said Dave Happel, CEO, Cognoa.
The device has:
- A mobile app for caregivers and parents to answer questions about behavior problems and to upload videos of their child
- A video analysis portal that allows manufacturer-trained and certified specialists to view and analyze uploaded videos of patients
- A healthcare provider portal to enable a provider to enter answers to pre-loaded questions about behavior problems, track the information provided by parents or caregivers, and review the results
After processing the information, the ASD Diagnosis Aid reports a positive or negative diagnosis if there is sufficient information of the algorithm to make a diagnosis. If there is insufficient information to render a “Positive for ASD” or a “Negative for ASD” result to help determine a diagnosis, the ASD Diagnosis Aid will report that no result can be generated.