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First-Of-Its-Kind FDA-Authorized Device for Early Diagnosis of Autism Spectrum Disorder Launches

FDA Clearance For the First Tool to Diagnose Autism in Children as Young As 16 Months
Southwest Autism Research & Resource Center engaged in pivotal research with Atlanta-based Marcus Autism Center in clinical studies of more than 1,500 children that demonstrated an eye-tracking device can help diagnose autism before the age of three years old

Marcus Autism Center, a subsidiary of Children’s Healthcare of Atlanta, has developed the first biomarker-based, eye-tracking diagnostic technology now available to help diagnose autism. The tool, called EarliPointTM Evaluation, is authorized for use in children between 16 and 30 months of age to aid in the diagnosis and assessment of autism. On Sept. 5, two research studies published in The Journal of The American Medical Association (JAMA) and JAMA Network Open present data to validate its use in the early diagnosis of autism.

The EarliPoint Evaluation tool measures children’s looking behavior to provide clinicians with objective measurements of each child’s strengths and vulnerabilities. In the studies published, these measurements predicted expert clinician assessments with a high degree of accuracy. Objective measurements can help speed the time to diagnosis and speed the start of individualized treatment plans for newly diagnosed children at younger ages, which has been shown to lead to better outcomes for children with autism. A recent study showed that earlier interventions can also decrease the lifetime costs of autism to families and society. 

“This technology is a first-of-its-kind, biomarker-based tool developed and clinically validated to aid in the diagnosis of autism,” said Ami Klin, PhD, Director, Marcus Autism Center at Children’s Healthcare of Atlanta and Division Chief of Autism and Developmental Disabilities at Emory University School of Medicine. “The published studies show that objective, performance-based biomarkers of children’s looking behavior can help clinicians by reducing the time required for accurate autism diagnosis from multiple hours of clinician assessment to as little as 12 minutes of objective measurements. The tool collects data at 120 times per second and, within 12 minutes of video watching, we can compare moment-by-moment looking behavior of a child and measure thousands of divergencies to compare to typically developing peers.”

Dr. Klin noted, “Testing results were highly consistent with expert clinical diagnoses and gold standard assessments of each child’s needs which are critical data for developing personalized treatment plans to enable the greatest gains for children.”

Bringing a national tool to a local level

Six partner sites were selected by Marcus Autism Center to participate in testing the effectiveness of the EarliPoint Evaluation tool. In Arizona, Southwest Autism Research & Resource Center (SARRC), nationally recognized for its clinical excellence and exceptional productivity in cutting edge research for the autism community, was one of the chosen collaborators to test the diagnostic accuracy of the tool.

Autism affects 1 in 36 children according to the CDC, meaning that each year, in the U.S. alone, more than 90,000 children with autism are born. Early identification and early intervention are important for supporting the health, learning, and long-term well-being of all children with autism. However, early diagnosis is still a work in progress.

Christopher J. Smith, PhD, Chief Science Officer at SARRC shares, “A child’s early 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.”

In 2018, 120 SARRC families participated in the study in a little over one year. Families that participated in the study were seeking an evaluation for their child or had a typically developing child and wanted to help advance science. During a three-to-four-hour visit to SARRC, psychologists completed the traditional gold-standard developmental evaluation, and research staff conducted the 20-minute experimental eye-tracking protocol. Participating families and SARRC’s team were blind to the results of the eye-tracking protocol, and the eye-tracking researchers were blind to the results of the traditional evaluation. Parents received the results from the traditional evaluation.

Dr. Smith shares, “This technology represents a significant breakthrough in our ability to diagnose as early as possible. We were thrilled that SARRC’s team could be a part of this groundbreaking research, especially given this work is highly consistent with our efforts to improve screening and diagnosis of autism. We’re excited to see what the future holds for the early identification of autism in communities everywhere.”

Transforming autism diagnosis and outcomes

By enabling accurate and early diagnosis, EarliPoint Evaluation has the potential to help clinicians change the trajectory of children’s lives and help empower the healthcare system to better address autism in the U.S. – and beyond.

“If diagnosed earlier, child and family supports can also happen earlier. Earlier supports help children by capitalizing on greater neuroplasticity at younger ages. Currently, only one in four children with autism is identified before age three. Our hope is that this tool can help alleviate this enormous public health challenge with earlier diagnoses and treatment,” said Warren Jones, PhD, lead author, Director of Research at Marcus Autism Center at Children’s Healthcare of Atlanta and Nien Distinguished Chair in Autism at Emory University School of Medicine. “The implications of these results are that children who face long wait times and multiple referrals before being diagnosed at age four or five may now be able to obtain a diagnosis before age three.”

Twenty years of research leads to significant breakthrough

Researchers Drs. Ami Klin and Warren Jones spent more than 20 years studying early signs of autism to develop an effective and objective biomarker to aid in early diagnosis. Results of clinical studies published simultaneously in the Journal of the American Medical Association (JAMA) and in JAMA Network Open now demonstrate the efficacy of the tool.

Moving from lab-based research to clinical practice following FDA authorization, the tool was used for the first time in clinic on August 7, 2023, at Marcus Autism Center. In early trials of the device, researchers often referred to it as “the Marcus Test,” acknowledging leading philanthropist Bernie Marcus, founder of Marcus Autism Center, who has made this breakthrough possible through his philanthropic efforts and support of ASD research.

To use the device, children watch video scenes of social interaction on a portable tablet. As they watch, their looking behavior is monitored moment-by-moment to determine what social information the children look at and what they do not. Reviewing the data, which includes a personalized and detailed report with visualizations from the test, clinicians use the tool to provide the family with a timely and objective diagnosis, together with measures of the levels of each child’s social disability, verbal ability, and non-verbal learning skills. These results help clinicians to then work with the family on an individualized treatment plan.

The EarliPoint Evaluation tool, which recently received FDA authorization for the second generation of the device, is small, portable and accessible for clinicians to use in an office setting. Further, it can be operated remotely anywhere there is internet connectivity, enabling providers nationwide to use this technology – even in the most remote communities – to allow for earlier, more equitable and more efficient identification and treatment for ASD.

Marcus Autism Center is one of the country’s leading centers in research, diagnosis and treatment of autism in children, and has continued to be at the forefront of science-based care since its founding. Clinicians at Marcus Autism Center have been focused on addressing one of the key elements of autism in children: diagnosing autism earlier in kids. Early identification and early intervention are important for supporting the health, learning, and long-term well-being of all children with autism spectrum disorder.

Children’s Healthcare of Atlanta has intellectual property interests in the EarliPoint device and, along with Drs. Jones and Klin, equity interest in EarliTec Diagnostics, Inc. As a result of these interests, Children’s Healthcare of Atlanta and Drs. Jones and Klin could potentially benefit financially from the sale of the EarliPoint device.

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