EarliTec Diagnostics Receives FDA 510(k) Authorization for Next-Generation EarliPoint Evaluation for Autism Spectrum Disorder

Staff Report

Friday, July 14th, 2023

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) authorization of the second generation of its EarliPoint™ Evaluation for ASD for children ages 16-30 months old. The company also announced the commercial launch for EarliPoint, which enables EarliTec to work with providers on introducing EarliPoint Evaluation and helps deliver on the company’s mission of making earlier and more efficient identification and treatment for ASD accessible to children everywhere.

“Early diagnosis can make all the difference in helping children with autism get the support they need to develop essential language and communication, social, and cognitive skills. The brains of infants and young children show remarkable neuroplasticity, forming millions of neural connections as they learn and experience new things like social interaction,” said Sarabeth Broder-Fingert M.D., M.P.H. and a member of EarliTec’s Clinical Advisory Board. “By enabling clinicians to make earlier diagnoses, EarliPoint has the potential to help families take advantage of this plasticity and tailor interventions to help their children as needed to ultimately live their best and happiest lives. EarliPoint also holds the potential to enhance equity in autism diagnosis. The current standard of care leads to substantial inequity, I am optimistic that EarliPoint’s accessible design will allow for more equitable diagnosis and treatment.”

Conducted by qualified healthcare providers, the updated EarliPoint Evaluation displays curated scenes of social interactions on a portable tablet. Eye-tracking technology measures more than 120 focal preferences per second. 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. Upon review of the data, including a personalized and detailed report, with visualizations from the test, clinicians have a timely, objective and accurate reading of the presence of autism, the severity of the child’s social disability, and the child’s level of verbal ability and non-verbal learning.

The journey to develop EarliPoint’s technology started more than a decade ago, and it was brought to market and developed largely by the philanthropic support of Bernie Marcus of The Marcus Foundation, with additional investments made by the Georgia Research Alliance.

ASD is a common neuro-developmental condition that affects 1 in every 36 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, but the median age for diagnosis in the U.S. is much later, at age 4-5  years. For children of U.S. racial and ethnic minorities, low-income and rural families, as well as girls with autism, this age is often even later.

“Although the prevalence of autism is growing, our healthcare system is missing a critical developmental window for children. Our goal is to help parents and care providers access earlier autism diagnosis during the life stage when interventions can be most impactful,” said Tom Ressemann, EarliTec’s Chief Executive Officer. “In most cases, EarliPoint Evaluation can be completed in an existing appointment. With EarliPoint’s efficiency, we anticipate that providers can shrink waitlists and help caregivers understand more quickly if their child has ASD. We are focused on building more equitable access to early diagnosis. The next generation of EarliPoint marks an exciting milestone in our work toward a more rewarding life for all children with ASD and their families.”

EarliTec’s technology quantifies Social-Visual Engagement by measuring 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 EarliPoint Severity Indices that correlate with levels of social disability, verbal ability and non-verbal learning as measured by clinicians using current goldstandard tools. By directly measuring a child’s moment-by-moment preferential attention to critical social information in the environment, EarliPoint provides the first objective ASD diagnostic and assessment tool for providers.