FDA approves ASD diagnostic tool

Digital health company EarliTec Diagnostics Inc. announced it has received FDA clearance for its evaluation tool to diagnose autism spectrum disorder in children aged 16 to 30 months.

According to a press release from EarliTec, EarliPoint Evaluation was granted clearance based on positive results from two studies, a clinical trial as well as a repeatability and reproducibility study, in which more than 500 individuals were enrolled. Clinical data demonstrated the tool “safely, consistently and effectively” delivered an ASD diagnosis and measured a child’s level of social disability and cognitive ability.

“EarliTec was founded to advance ASD care by developing new approaches to diagnosing, monitoring and treating children. Better understanding the clinical progression and symptoms for individuals can result in tailored interventions to achieve the greatest gains,” EarliTec CEO Tom Ressemann said in the release.

EarliTec’s technology utilizes Dynamic Quantification of Social-Visual Engagement, which captures a child’s moment-by-moment looking behavior that is imperceptible to the human eye. The diagnostic tool is also able to assist in the early identification of ASD and provides EarliPoint Severity Indices, which correlate to levels of social disability and verbal and non-verbal ability.

By directly measuring a child’s preferential attention to critical social information in any given environment, EarliPoint seeks to become the first objective diagnostic tool for providers. Conducted by a trained technician, the evaluation involves a child watching a brief series of video scenes depicting social interactions between children. Eye tracking technology monitors the child’s focus and responsiveness, and using patented analysis technology, these data are compared with age-expected reference metrics to determine if the child is missing key moments of social learning.

“We look forward to advancing our ongoing partnerships with clinicians who can use EarliPoint Evaluation to identify young children with autism and help children and families get the interventions and support that are most beneficial,” Ressemann added.