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

ATLANTA, GA (Sep. 5, 2023) - 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. Two research studies published today 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 today, 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 a 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.”

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.

Over the past 35 years, Bernie Marcus has provided philanthropic support of more than $120 million in giving to develop innovative treatment, research and comprehensive care for autism, leading to a number of advancements, including the eye-tracking technology developed at the Marcus Autism Center. He founded Marcus Autism Center in 1991 to increase access to research and treatment for children diagnosed with autism. One of the crowning achievements of his life’s work in autism has been the development of the Marcus Test to diagnose children earlier and get them into individualized treatment sooner to help improve outcomes.

“We are all very grateful to Bernie Marcus for his extraordinary generosity to make this important innovation possible for children and families,” said Donna Hyland, Children’s CEO. “Marcus Autism Center is a leader in research, diagnosis and treatment of autism and understanding earlier identification leads to better outcomes for all children with autism spectrum disorder. This tool is another example of the wonderful bench-to-bedside clinical expertise we provide to patients in Georgia and throughout the country.”

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.