EarliTec Diagnostics Receives FDA 510(k) Clearance for the EarliPoint Evaluation for Autism Spectrum Disorder

ATLANTA–(BUSINESS WIRE)–EarliTec Diagnostics, Inc. (“EarliTec”), a digital health company developing novel diagnostic and therapeutic products for children with autism spectrum disorder (ASD) and early childhood vulnerabilities, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the EarliPoint^™ Evaluation for ASD for children ages 16-30 months. The EarliPoint Evaluation is the first objective measurement tool to assist clinicians in the diagnosis and assessment of ASD. Clinical data show the tool safely, consistently and effectively delivers an ASD diagnosis and measures a child’s 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,” said Dr. Christopher J. Smith, Chief Science Officer at the Southwest Autism Research and Resource Center. “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.”

ASD is a common neuro-developmental condition that affects 1 in every 44 children, more than all childhood cancers, juvenile diabetes, and heart disease combined.¹ Many parents suspect symptoms of autism in the first 18 months of life.² However, the median age for diagnosis in the U.S. is much later, at age 4-5 years, and later still in children from minority and low-income families.³

Early intervention is one of the most important factors for improving lifetime outcomes, yet prolonged diagnostic journeys delay the possibility of treatment, said Tom Ressemann, Chief Executive Officer of EarliTec.

“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,” Ressemann said. “Today’s 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.”

EarliTec’s technology utilizes Dynamic Quantification of Social-Visual Engagement (DQSVE), which captures a child’s moment-by-moment looking behavior that is otherwise imperceptible to the human eye. EarliTec’s EarliPoint Evaluation can assist in the early identification of ASD and provides the EarliPoint Severity Indices that correlate with the levels of social disability and verbal and non-verbal ability.

By directly measuring a child’s preferential attention to critical social information in the environment, EarliPoint provides the first objective diagnostic tool for providers. Conducted by a trained technician, the evaluation involves a child watching a series of short 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 to age-expected reference metrics to determine if the child is missing key moments of social learning.

“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 EarliPoint Evaluation was granted clearance based on positive results from two studies, a pivotal clinical trial and a repeatability and reproducibility study, in which more than 500 individuals were enrolled. These studies were preceded by a feasibility trial involving more than 1,000 children. The FDA 510(k) clearance represents the first regulatory milestone for the company, with plans to continue clinical research and deepen partnerships within the ASD community that will enable optimal clinical outcomes to best meet patient and caregiver needs.

EarliTec’s recently announced $19.5 million financing, led by Bernie Marcus with participation from the Georgia Research Alliance, was used to support the FDA submission and the development of the technology created by researchers at Children’s Healthcare of Atlanta, Emory University School of Medicine and Yale University.

ABOUT AUTISM

Autism spectrum disorder (ASD) affects roughly 1 in 44 children, more than all childhood cancers, juvenile diabetes and heart disease combined.¹ While many parents suspect symptoms of autism in the first 18 months of life, the median age for diagnosis in the U.S. remains four to five years of age.² Lack of access to expert clinicians and other disparities in care can further delay diagnosis. Prolonged diagnosis delays the possibility of treatment in a situation where early intervention is one of the most important factors for improving lifetime outcomes.

ABOUT EARLITEC DIAGNOSTICS

EarliTec Diagnostics is a digital health company making earlier identification and treatment for ASD and related disabilities accessible to children everywhere. Developed by leading researchers at Children’s Healthcare of Atlanta, Emory University School of Medicine and Yale University, EarliTec is pioneering the development of biomarkers that help parents, providers and caregivers understand how a child is viewing the world. The company’s initial product, the EarliPoint^™ Evaluation for Autism Spectrum Disorder, is the first objective measurement tool that clinicians can use to assist in the detection and assessment of ASD in children as young as 16 months of age.

1. Centers for Disease Control and Prevention. (2021, December 2). Data & statistics on autism spectrum disorder. Centers for Disease Control and Prevention. Retrieved March 31, 2022, from https://www.cdc.gov/ncbddd/autism/data.html
2. Chawarska, K., Paul, R., Klin, A., Hannigen, S., Dichtel, L. E., & Volkmar, F. (2007). Parental recognition of developmental problems in toddlers with autism spectrum disorders. J Autism Dev Disord, 37(1), 62-72. https://doi.org/10.1007/s10803-006-0330-8
3. Constantino, J. N., Abbacchi, A. M., Saulnier, C., Klaiman, C., Mandell, D. S., Zhang, Y., Hawks, Z., Bates, J., Klin, A., Shattuck, P., Molholm, S., Fitzgerald, R., Roux, A., Lowe, J. K., & Geschwind, D. H. (2020). Timing of the Diagnosis of Autism in African American Children. Pediatrics, 146(3). https://doi.org/10.1542/peds.2019-3629