FDA Grants EarliTec Diagnostics 510(k) Authorization for Advanced EarliPoint Assessment in Autism Spectrum Disorder
Friday, July 14, 2023
EarliTec Diagnostics, Inc., a digital health company focused on developing diagnostic and therapeutic products for children with autism spectrum disorder (ASD) and early childhood vulnerabilities, has announced that the U.S. Food and Drug Administration (FDA) has granted them 510(k) authorization for the second generation of their EarliPoint™ Evaluation for ASD. This authorization applies to children between the ages of 16 and 30 months. EarliTec has also launched the commercial availability of EarliPoint, enabling them to collaborate with healthcare providers to introduce the evaluation and fulfill their mission of providing earlier and more accessible identification and treatment for ASD in children.
The timely diagnosis of autism can significantly impact a child's development by ensuring they receive the necessary support for language and communication, social interaction, and cognitive skills. Infants and young children have remarkable neuroplasticity, with their brains forming numerous neural connections as they learn and engage in social experiences. EarliPoint aims to facilitate earlier diagnoses, enabling families to take advantage of this neuroplasticity and tailor interventions to their child's specific needs, leading them to live happier and more fulfilling lives. Additionally, EarliPoint has the potential to address disparities in autism diagnosis, as the current standard of care often results in inequitable access to diagnosis and treatment. By design, EarliPoint promotes greater equity and accessibility.
The updated EarliPoint Evaluation is conducted by qualified healthcare providers and utilizes a portable tablet that displays curated scenes of social interactions. Eye-tracking technology measures more than 120 focal preferences per second, which are then compared to age-expected reference metrics. This analysis helps determine if the child is missing important moments of social learning. Clinicians receive a personalized and detailed report, including visualizations from the test, providing an objective and accurate assessment of autism presence, the severity of social disability, and the child's level of verbal and non-verbal learning abilities.
Autism spectrum disorder affects approximately 1 in 36 children, surpassing the prevalence of childhood cancers, juvenile diabetes, and heart disease combined. Despite many parents suspecting autism symptoms within the first 18 months of their child's life, the average age of diagnosis in the U.S. remains around four to five years, leading to disparities in outcomes, particularly among minority populations. Limited access to expert clinicians and disparities in care further contribute to delayed diagnosis, impeding early intervention, which is crucial for improving long-term outcomes. EarliTec's goal is to help parents and caregivers access earlier autism diagnosis during the critical developmental stages where interventions can have the greatest impact.