Autism spectrum disorder, or known as ASD, has lifelong impacts, where difficulty in socialization occurs— especially in terms of social interaction and communication. Additionally those with ASD exhibit very specific, structured, and repetitive patterns or methods of behavior. ASD affects around 1 in 54 children in the U.S., but this number may be even higher. ASD testing is lengthy, expensive, and hard to access, so many suspecting parents tend to delay this disagonist process. The conventional method to diagnose ASD is done through a clinician who has expertise in either developmental pediatrics, child neurology, or psychiatry. Due to the lengthy clinical assessments, standardized testing batteries, and overall complexity, this evational process highlights the healthcare inequality in America, as those who are nonwhite, come from a low socioeconomic status, and are female tend to have the largest delays in diagnosis.
There is good news, however!
To address these challenges, a team of researchers has been developing technologies aimed at making an ASD evaluation simpler and more accessible. The FDA recently approved a newly developed device called CanvasDx for this purpose. This device is intended for use in both primary care and clinical assessment settings. This can help to establish a diagnosis of ASD in children ages 18 months to 5 years who show symptoms that may be ASD, the typical age range for accurate diagnosis. The idea behind the device is to target the most important parts of the ASD evaluation and to condense it into a much shorter form that is easier to access.
How does CanvaDx work?
There are three components to the evaluation. First, the parent or guardian answers a brief questionnaire featured on the app. Second, families upload video-clips of their child during play or mealtimes, which are then reviewed by video analysts for signs of ASD. Third, medical providers answer a small set of questions within a database. From there an algorithm compiles the information gathered from those three sections and provides a result of either "ASD," "no ASD," or "indeterminate."
Preliminary data on 425 research participants who used the device was presented at the Pediatric Academic Societies meeting earlier this year. Children were evaluated using the device, and also by a group of autism specialists. The device indicated a diagnosis of ASD or no ASD in just under one-third of patients, while the majority of patients received an indeterminate result. If the device determined that a child had ASD, it was correct in about 80% of the children. If the device determined that a child did not have ASD, it was almost always correct.
Most of the patients with an indeterminate result had various forms of developmental delays that were more difficult to determine, including ASD and other neurodevelopmental disabilities.
What is CanvaDx’s future impact?
Overall, the Canvas Dx device may prove to be a very useful tool in the primary care setting, as it can accelerate ASD diagnosis in some children— especially in those who exhibit worrisome symptoms— and to accurately discern those who are unlikely to have ASD. This may help accelerate and streamline the process of diagnosing ASD, and could limit long waits for specialized evaluations. While the initial data suggests that there are high rates of uncertainty, particularly in children with complex neurodevelopmental presentations, primary care providers will be prompted to pursue further neurodevelopmental evaluation for those children.
It is important to note that the device does not stand alone, but should be combined with clinical assessment by the primary care team. However, specialist referrals will still be important to provide long-term neurodevelopmental care— something that health-care providers need to make more accessible. Advocacy to ensure that ASD diagnoses made using the device are recognized by insurance companies, education systems, and treatment agencies may be needed. Overall, there is hope that a device such as this may help children with ASD to be diagnosed, and to receive appropriate interventions as early as possible to optimize their development.
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