Expanded indication enables broader access to objective, biomarker-based autism assessment and measurement of outcomes over time
Plymouth, MN, March 12, 2026 — EarliPoint Health today announced that the U.S. Food and Drug Administration (FDA) has granted clearance for an expanded age indication for the EarliPoint System, extending use through 95 months (7 years). The clearance allows EarliPoint to support qualified clinicians in the diagnosis and assessment of Autism Spectrum Disorder (ASD) in children ages 16 months through 95 months who are at risk based on concerns identified by a parent, caregiver, or healthcare provider.
To date, thousands of children have been assessed using EarliPoint in clinical and real-world settings. The expanded indication significantly broadens access to EarliPoint’s objective, eye-tracking–based assessment at a time when many children are still not referred for diagnostic evaluation until later in childhood.
“We can optimize children’s outcomes for their lifetimes if we diagnose and intervene in toddlerhood, and that is why we focused our first FDA indication on infants and toddlers”, said Dr. Ami Klin, Scientific Co-Founder of EarliPoint Health. “But 4 of every 5 children with autism are diagnosed at later ages. This expanded clearance allows us to now extend objective and cost-effective diagnosis and assessment to the vast majority of families who have waited, sometimes for years, to gain access to these services. And we will do so with the same level of scientific rigor, accuracy and precision as we have done on behalf of younger children, helping clinicians support families with greater confidence and clarity.”
Addressing Real-World Diagnostic Delays
Despite growing awareness of autism and developmental delays, long wait times and limited specialist availability continue to delay evaluations during critical developmental windows. By expanding the cleared age range, EarliPoint enables providers to offer an objective, biomarker-based assessment to children who might otherwise face prolonged uncertainty.
The EarliPoint System uses eye-tracking technology to measure social visual engagement, producing standardized, objective data to support clinical decision-making. The system is intended to complement clinician judgment by adding quantifiable insights within existing diagnostic workflows.
Measuring Progress Over Time
In addition to supporting diagnosis, the expanded age indication allows clinicians to use EarliPoint with children across a longer developmental window. This enables treatment providers to track progress over time as children receive intervention services, resulting in more objective data to inform outcomes and greater transparency for families and payors.
“This clearance is not just about diagnosis,” Pagliaro added. “It’s about understanding progress over time. Families and providers want objective ways to assess whether interventions are making a meaningful difference, and EarliPoint helps bring that clarity to the care journey.”
This capability supports a more measurement-based approach to care, aligning with the broader movement toward accountability, transparency, and outcomes-focused decision-making in pediatric and behavioral health.
Commercial Impact and Market Expansion
The expanded FDA clearance represents a significant growth opportunity for EarliPoint’s existing provider partners, enabling broader use across early childhood, diagnostic, and treatment settings, as well as accelerating adoption among new customers.
“For our current customers, this expands the population they can serve with EarliPoint,” said Pagliaro. “For providers evaluating new solutions, FDA clearance through age seven reinforces trust, clinical validation, and relevance across the full early childhood care continuum.”
About EarliPoint Health
EarliPoint Health is a health technology company transforming the standard of care for autism. Through FDA-authorized eye-tracking technology and visual attention biomarkers, EarliPoint provides objective, rapid assessments of social, verbal, and non-verbal skills in children as young as 16 months. The platform supports both early diagnosis and ongoing assessment, enabling more timely, personalized, and effective interventions. To learn more, visit earlipointhealth.com and connect with us on LinkedIn.
