Marcus Autism Center Launches FDA-Cleared Device for Early Diagnosis of Autism Spectrum Disorder

Newswise — Atlanta (September 5, 2023) ­Marcus Autism Centersubsidiary company Children's Health of Atlanta, developed the first biomarker-based, eye-tracking diagnostic technology now available to help diagnose autism. A tool called EarlyPointTM The assessment is approved for use in children ages 16 to 30 months to aid in the diagnosis and assessment of autism. Two research studies were published today Journal of the American Medical Association (JAMA) and The JAMA Network is open provide data to support its use in the early diagnosis of autism.

The EarliPoint Evaluation tool measures children's outward behavior to provide clinicians with objective measurements of each child's strengths and weaknesses. In studies published today, these measurements predicted expert clinician assessments with high accuracy. Objective measurements can help speed up diagnosis times and initiate individualized treatment plans for newly diagnosed children at a younger age, which has been shown to lead to better outcomes for children with autism. A A recent study It has been shown that early interventions can also reduce the lifetime costs of autism to families and society.

“This technology is a first-of-its-kind, biomarker-based tool that has been developed and clinically validated to aid in the diagnosis of autism,” said. Amy Cline, PhD, director of the Marcus Autism Center at Children's Healthcare of Atlanta and chief of the Division of Autism and Developmental Abilities at Emory University School of Medicine. “Published research shows that objective, performance-based biomarkers of children's appearance can help clinicians reduce the time needed to accurately diagnose autism from hours of clinician assessment to 12 minutes of objective measurement.” The tool collects data 120 times per second, and within 12 minutes of watching a video, we can compare a child's moment-to-moment behavior and measure thousands of differences to compare with typically developing peers.

Dr. Cliny noted, “The test 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 maximize child benefit.”

Transforming autism diagnosis and outcomes
By enabling accurate and early diagnosis, the EarliPoint Evaluation has the potential to help clinicians change the trajectory of children's lives and help strengthen the health care system for autism in the US and abroad.

“If diagnosed earlier, support for the child and family can be provided earlier.” Early supports help children at a younger age by increasing neuroplasticity. Currently, only one in four children with autism is diagnosed before the age of three. It is our hope that this tool will help alleviate this enormous public health challenge through early diagnosis and treatment,” said. Warren Jones, PhD, lead author, director of research at the Marcus Autism Center in Atlanta Child Health and the Nien Distinguished Chair in Autism at Emory University School of Medicine. “The implications of these results are that children who faced long waits and multiple referrals before being diagnosed at four or five years of age can now receive a diagnosis by age three.”

Twenty years of research leads to significant breakthrough
Researchers Dr. Amy Cline and Warren Jones have been studying the early signs of autism for more than 20 years to develop an effective and objective biomarker to aid in early diagnosis. Clinical trial results were published simultaneously Journal of the American Medical Association (JAMA) and within The JAMA Network is open Now show the effectiveness of the tool.

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

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

The EarliPoint Evaluation tool, which recently received FDA clearance for a second-generation device, is small, portable, and affordable for clinicians to use in an office setting. In addition, it can be administered remotely anywhere there is an Internet connection, allowing providers nationwide to use this technology – even in the most remote communities – for earlier, more equitable and effective identification and treatment of ASD.

The Marcus Autism Center is one of the nation's leading centers for the research, diagnosis and treatment of childhood autism and has continued to be at the forefront of science-based care since its inception. Clinics at Marcus Autism Center focus on one of the key elements of autism in children: early diagnosis of autism in children. Early identification and early intervention are important to support the health, learning and long-term well-being of all children with autism spectrum disorders.

Over the past 35 years, Bernie Marcus has provided more than $120 million in philanthropic support for innovative autism treatments, research and comprehensive care, leading to many advances, including the eye-tracking technology developed at the Marcus Autism Center. . He founded the Marcus Autism Center in 1991 to advance research and treatment for children diagnosed with autism. One of the crowning achievements of his life in autism was the development of the Marcus test to diagnose children earlier and place them in individualized treatment earlier to help improve outcomes.

“We are all very grateful to Bernie Marcus for his extraordinary generosity to make this important news for children and families possible,” he said. Donna Hyland, Children's Executive Director. “Marcus Autism Center is a leader in autism research, diagnosis and treatment, and understanding that early identification leads to better outcomes for all children with autism spectrum disorders. This tool is another example of the wonderful clinical expertise we provide to patients in Georgia and across the country.”

Children's Healthcare of Atlanta has intellectual property interests in the EarliPoint device and Drs. Jones & Cline, Equity Interest in EarliTec Diagnostics, Inc. As a result of these interests, Atlanta Children's Health and Dr. Jones and Cline may benefit financially from the sale of the EarliPoint device.


About the Marcus Autism Center
The Marcus Autism Center is a nonprofit organization and subsidiary of Children's Healthcare of Atlanta that treats more than 5,000 children a year with autism and related disorders. As one of the largest autism centers in the US, Marcus Autism Center offers families access to the latest research, comprehensive assessments and intensive behavioral treatments. Through research grants, community support and government funding, the Marcus Autism Center aims to maximize the potential of children with autism today and transform the nature of autism for generations to come.

About Children's Health of Atlanta
As the only independent pediatric health system in Georgia, Children's Health Atlanta is a trusted leader in pediatric care. The nonprofit organization's mission is to make children better today and healthier tomorrow through more than 60 pediatric specialties and programs, top healthcare professionals, and leading research and technology. Children's is one of the largest providers of pediatric clinical care in the country, managing more than a million patients annually in three hospitals, the Marcus Autism Center, the Advanced Pediatric Center, urgent care centers and community centers. Consistently ranked among the top children's hospitals by US News & World Report, Children's Healthcare of Atlanta has impacted the lives of children in Georgia, the United States and around the world for more than 100 years through generous community support.

About Emory University School of Medicine
Emory University School of Medicine is a leading institution with the highest standards in education, biomedical research and patient care, with a commitment to attracting and developing a diverse group of students and innovative leaders. Emory School of Medicine has more than 3,400 full- and part-time faculty, 592 medical students, 497 allied health students in five programs, 1,388 residents and fellows in 115 accredited programs, and 92 MD/PhD students. Medical school faculty received $588.4 million in external research funding in fiscal year 2022. The school is best known for infectious disease, brain health, heart disease, cancer, transplantation, orthopedics, pediatrics, kidney disease, ophthalmology and geriatrics.