FDA OKs First Digital Health Tool to Diagnose, Assess Autism in Children

Digital health company EarliTec has earned U.S. Food and Drug Administration (FDA) 510(k) clearance of its EarliPoint Evaluation for autism spectrum disorder (ASD) for children aged 16-30 months.
 
EarliPoint Evaluation is the first objective measurement tool to help clinicians diagnose and assess ASD. Clinical data from two trials consisting of over 1,500 patients has shown the tool safely, consistently, and effectively delivers ASD diagnosis and measures the level of social disability and cognitive ability.
 
“A child’s formative years are critical, filled with rapid cognitive, social, emotional and physical development. Sometimes differences in development are so subtle that parents and pediatricians are hesitant to act until delays become more problematic. It’s important to have clear, definitive information about these differences, so interventions can begin as soon as possible,” Dr. Christopher J. Smith, chief science officer at the Southwest Autism Research and Resource Center, told the press. “We need to take full advantage of the brain’s neural plasticity in the early developmental time period. EarliPoint represents a breakthrough that utilizes solid empirical data to facilitate earlier diagnosis of ASD. It literally gives years back to families that are better spent on intervention rather than waiting.”
 
Early intervention for the common neuro-developmental condition is an important factor to improve lifetime outcomes, but a prolonged diagnostic process can delay possibility for treatment.
 
“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,” said EarliTec CEO Tom Ressemann. “This clearance is an exciting first step, and 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.”
 
The tool measures preferential attention to critical social information in the environment. A trained technician evaluates the child as they watch a series of short video scenes showing social interactions between children. Eye-tracking technology monitors focus and responsiveness using analysis tech. The data is then compared to age-expected reference metrics to determine if key moments of social learning are missed.
 
“This is a significant milestone as we continue to develop innovative technologies designed to improve the lives of children and families affected by autism,” said Sreeni Narayanan, chief technology officer of EarliTec. “How we quantify moment-by-moment behavior of a child not only provides objective measures of each child’s strengths and weaknesses today—measures that can be universally available and accessible to all families—it provides a digital health platform that can support care in the future, so that all individuals affected by autism receive timely, individualized care.”

The company also recently received $19.5 million financing, which was used to support the FDA submission.