EarliTec Diagnostics has raised $19.5m financing to support the early diagnosis and treatment of autism spectrum disorder (ASD) in children.

Led by Bernie Marcus, the Series A investment round has also seen participation from the Georgia Research Alliance (GRA).

EarliTec intends to use the financing to support the US Food and Drug Administration (FDA) for 510(k) approval, marketing and expansion of its digital biomarkers, developed based on its unique multimodal AI platform.

EarliTec CEO Tom Ressemann said: “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.

“With this insight, we can help parents, providers and caregivers, access earlier diagnosis at a time when effective intervention dramatically improves lifetime outcomes.”

EarliTec is a digital health company, engaged in developing novel diagnostic and therapeutic products for children with ASD and early childhood vulnerabilities.

According to the company, early identification and intervention are significant factors in improving lifetime outcomes for children with ASD.

It leverages Dynamic Quantification of Social-Visual Engagement (DQSVE) technology for its investigational device EarliPoint Evaluation for Autism Spectrum Disorder.

The device objectively diagnoses ASD and quantifies individual severity at very early times, said the company.

EarliTec has completed clinical trials with more than 1,500 children, and has secured the FDA breakthrough status for its EarliPoint system, in April last year.

The trials were carried out leveraging technology developed by leading researchers at Children’s Healthcare of Atlanta, Emory University School of Medicine and Yale University.

The Home Depot co-founder Bernie Marcus said: “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. We are thrilled to be at the forefront of this innovation and to support the evolution of this technology.”