Editor: What To Know
- The company's initial product, the EarliPoint® Evaluation for Autism Spectrum Disorder received breakthrough status from the FDA as it seeks to be the first objective, clinically validated measure of individual ASD status and severity in children as young as 16 months of age.
- For a child, it is as simple as watching a video — like scenes of toddlers playing — while the device assesses the individual focal points at a rate of 120 times per second.
- “The difference that early identification makes in securing help and support during a very difficult time is significant and can ultimately transform the lives of children with autism and their families,” said Bernie Marcus, co-founder of The Home Depot.
EarliTec Dx, Inc. (“EarliTec”), a digital health company developing novel diagnostic and therapeutic products for children with Autism Spectrum Disorder (ASD) and early childhood vulnerabilities, announced today a $19.5 million financing to further its mission of making earlier ASD identification and treatment accessible to children everywhere. Bernie Marcus led the Series A round with participation from the Georgia Research Alliance (GRA).
In 2021, the CDC reported that approximately 1 in 44 children in the U.S. are diagnosed with ASD. Early identification and intervention are significant factors in improving lifetime outcomes for children with ASD; however, limited access to skilled clinicians and other disparities often delay diagnosis until after the age of four. EarliTec Dx is the first company to use Dynamic Quantification of Social-Visual Engagement (DQSVE) to objectively diagnose ASD and quantify individual severity at very early ages.
“The difference that early identification makes in securing help and support during a very difficult time is significant and can ultimately transform the lives of children with autism and their families,” said Bernie Marcus, co-founder of The Home Depot. “We are thrilled to be at the forefront of this innovation and to support the evolution of this technology.”
With technology developed by leading researchers at Children’s Healthcare of Atlanta, Emory University School of Medicine, and Yale University, the company has completed clinical trials with more than 1,500 children—receiving breakthrough status for the EarliPoint® system in April of last year.
This round of financing will be used to support filing with the U.S. Food and Drug Administration (FDA) for 510(k) clearance, commercialization, and expansion of EarliTec’s digital biomarkers built on a proprietary multimodal AI platform.
“EarliTec’s ability to measure clinically relevant responses to unscripted social situations is revolutionizing our understanding of the way in which young children with autism learn about their social world,“ said Tom Ressemann, CEO of EarliTec. “With this insight, we can help parents, providers and caregivers, access earlier diagnosis at a time when effective intervention dramatically improves lifetime outcomes.”
The EarliPoint® Evaluation for Autism Spectrum Disorder is an investigational device utilizing Dynamic Quantification of Social-Visual Engagement (DQSVE), to capture moment-by-moment looking behavior imperceptible to the human eye.
For a child, it is as simple as watching a video — like scenes of toddlers playing — while the device assesses the individual focal points at a rate of 120 times per second. Each data point is then compared to thousands of discrete measurements within a clinically validated database, to provide a timely, objective, and accurate read of potential developmental disabilities.
ABOUT AUTISM & DELAYED DIAGNOSIS AND TREATMENT
Affecting roughly 1 in 44 children, Autism Spectrum Disorder (ASD) is more prevalent than all childhood cancers, juvenile diabetes and heart disease combined. While many parents suspect symptoms of autism before twelve months of age, the median age for diagnosis in the U.S. remains 4-5 years of age. Lack of access to expert clinicians and other disparities can extend the age at which a child is diagnosed. Prolonged identification 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 Dx 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 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 received breakthrough status from the FDA as it seeks to be the first objective, clinically validated measure of individual ASD status and severity in children as young as 16 months of age.
