Autism Spectrum Disorder (ASD) is difficult to diagnose at a young age as its symptoms vary widely between individuals. However, the earlier ASD is diagnosed, the sooner the child can receive treatments and therapies.
Biotechnology company Cognoa has developed the Canvas Dx platform to aid ASD diagnosis through a machine learning algorithm that assesses data from caregivers, healthcare providers, and portal specialists.
The Canvas Dx solution uses a mobile app that collects data and videos from the patient’s parents or caregivers. Here, healthcare providers can also answer questions and enter information about the child. Portal specialists also have access to the app, answering questions and analyzing videos of the patient.
The Food and Drug Administration tested Canvas Dx over five years with participation from 425 patients of the ages 18 months to five years old in 14 clinical care sites. These trials resulted in positive or negative results in 32% of patients.
Results from Canvas Dx were compared with results from a panel of clinical experts and 81% of the results matched. These studies proved Canvas Dx’s negative prediction success rate to be 98%. The technology also accurately determined that 78.9% of the patients did not have ASD.
The Director of the FDA's Center for Devices and Radiological Health, 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,"
The FDA has authorized Cognoa’s Canvas Dx tool, identifying risks that include misdiagnosis and delayed diagnosis. The FDA decided that the early detection benefits outweigh the risks and followed its
De Novo pathway and established special controls for the system.
Cognoa’s new detection software will allow patients to be diagnosed before the average age of 4.3 years old, allowing children with ASD to receive appropriate treatments and therapies at the most critical time in their development.