For Diagnosticians

Don’t Wait: Early Autism Diagnosis using the EarliPoint™ Evaluation

An objective tool to aid in the diagnosis of autism. EarliPoint measures social disability, verbal ability, and nonverbal learning while assisting with autism diagnosis in children under 3.

Developmental delays affect 1 in 6 children, and autism impacts 1 in 31 children under the age of 8. Without early diagnosis and intervention, children <3 years are at risk of falling further behind, missing critical milestones during the most important period of brain development.

Waiting to diagnose until school age can negatively affect long-term academic, social, and emotional outcomes, and the costs of delayed intervention are substantial-both in terms of the child’s development and healthcare costs.2-4 With the EarliPoint™ Evaluation, an objective assessment tool to aid in diagnosing autism, you can intervene early, which can lead to better outcomes for your patients and helping families avoid future challenges. 5-7

Watch this 1-minute EarliPoint™ overview video

The Challenge: Delays in Diagnosis and the Risk of Watchful Waiting

  • Delayed Diagnosis and Missed Opportunities: Most children with autism are not diagnosed until ages 4-5 or later.8,13 By this time, the most impactful phase of brain development has passed, reducing the effectiveness of interventions.2,13 Watchful waiting in the hope that children will “outgrow” delays can have devastating effects; waiting until school age can lead to missed opportunities for early, more effective interventions.2,9,10 Waiting longer increases the costs of treatment and limits the child’s potential.2,5,11

  • The Risk of Misdiagnosis: Traditional diagnostic methods, like ADOS-2, often rely on subjective behavioral observations, which can be influenced by clinician bias or miss key signs of autism in milder cases. This can lead to incorrect diagnoses or delays in appropriate interventions, further complicating the treatment process.2,7,13,17,18

The Solution: EarliPoint™ Evaluation System — Accurate, Objective, Early Diagnosis

EarliPoint™ is the only FDA-cleared tool designed to assist in diagnosis of autism in children as young as 16 months.5,15-16 By using true eye-tracking technology, EarliPoint™ measures social disability, verbal ability, and non-verbal learning – critical areas for assessing early signs of ASD.6-7 This objective, data driven assessment allows you to provide an accurate diagnoses, early intervention, which can lead to better long-term outcomes. 5-7,15-16

4 Key Benefits for Diagnosticians

  1. Objective, Data-Driven Insights: Traditional diagnostic methods, like ADOS-2, rely heavily on subjective observation and can be influenced by bias or uncertainty.11,17,18 EarliPoint™ provides clear, measurable data on social visual engagement, a key indicator of autism. Relative to expert clinical diagnosis, in a double-blind study of 719 children aged 16 to 30 months, EarliPoint demonstrated a diagnostic performance of 0.9 (1.0 is perfect) in children as young as 16 months.15 EarliPoint™ gives you confidence in your diagnosis.6,5

  2. Early Diagnosis, Early Intervention: Research shows that early intervention, especially before the age of 3, can dramatically improve long-term outcomes and can help children thrive academically and socially.12,13,10,9 Delaying diagnosis can lead to long-term developmental challenges and higher healthcare costs.10,4,3 EarliPoint™ helps you intervene earlier, avoiding the emotional, financial, and developmental consequences of waiting too long.6,5,7

  3. Assess Development Over Time: EarliPoint™ is not just for diagnosing, it’s also for ongoing assessments. By comparing future assessments with the initial diagnostic baseline, you can measure a child’s progress over time and adjust treatment plans as needed.14 This can help children receive data-driven care, providing the best possible chance for success.14

  4. Empower Parents and Build Trust: Parents often feel overwhelmed and unsure about the next steps after a diagnosis. By offering objective, measurable data, EarliPoint™ helps empower parents to make informed decisions about their child’s care.8,5 This clarity helps ease the emotional burden and builds trust, ensuring parents feel supported in the intervention process.8,4

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Overcome the Barriers to Early Diagnosis and Intervention

  • Objective Data: With EarliPoint™, you can present parents with clear, objective data associated with an autism diagnosis.8,5 This objective measurement allows parents to focus on what’s most important: ensuring their child receives the support they need.8,4

  • Improve Access for All Families: EarliPoint™ helps level the playing field, ensuring that children from all socio-economic backgrounds have access to accurate, early diagnosis.5-6 This eliminates biases, ensuring that every child has the opportunity to receive the best care from the outset.6,5

  • Increased Confidence in Your Clinical Decisions: With the support of EarliPoint™, you can make confident clinical decisions based on objective, reliable data.6,5 The tool acts as a partner in your diagnostic process, helping you navigate complex cases and providing clarity where traditional methods might fall short.6,5

  • Streamline Referrals and Intervention: The tool simplifies the referral process, reducing the time spent navigating complex diagnostic systems. By making earlier, more accurate referrals, you can ensure that children receive the timely interventions they need, avoiding delays that could hinder their progress.5,6,2

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Why Diagnosticians Choose EarliPoint™

  • FDA-Cleared and Objective Measurement: EarliPoint™ system using eye-tracking technology to assess social visual engagement in young children, making it a highly accurate and reliable tool to aid in diagnosing autism and assessing social disability, verbal ability and non-verbal learning in children as young as 16 months.5-6,15-16

  • Proven Diagnostic Performance: EarliPoint™ delivers diagnostic performance of 0.9 (1.0 is perfect) in comparison with the country’s leading experts, ensuring that you have reliable data at your fingertips to confidently assess children and guide them toward appropriate interventions.5,15-16 This system provides 20 years of research and validation conducted amongst the best US autism centers.15-16

  • Cost-Effective and Efficient: Early diagnosis with EarliPoint™ can lead to significant savings by reducing lifetime treatment costs, preventing long-term challenges, and improving outcomes.10,4 Intervening earlier can prevent the costs of missed developmental opportunities that can add up over time.10,4,3

  • Continuous Assessments: Unlike traditional diagnostic tools, EarliPoint™ allows for serial objective assessments of a child’s development, ensuring that you have the information you need to adjust care plans as children grow and develop.14-16

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Take Action: Don’t Wait — Intervene Early with EarliPoint™

The longer you wait to diagnose autism or developmental delays, the more difficult it becomes to intervene effectively.2-4 With EarliPoint™ as an aid, you can provide early, objective diagnoses. Early diagnosis can help to ensure better long-term outcomes for your patients. 5-6,9,15-16 Don’t risk the costs and emotional strain of delayed intervention — start using EarliPoint™ today and help transform your practice.2-4

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The EarliPoint System device is indicated as a tool to aid qualified clinicians in the diagnosis and assessment of Autism Spectrum Disorder (ASD) in children ages 16 months through 30 months, who are at risk based on concerns identified by a parent, caregiver, or healthcare provider. [Prescription Use Only]

References

1. Yu Y, Ozonoff S, Miller M. Assessment of Autism Spectrum Disorder. Assessment. 2024 Jan;31(1):24-41. doi: 10.1177/10731911231173089. Epub 2023 May 29. PMID: 37248660; PMCID: PMC10676043. https://pmc.ncbi.nlm.nih.gov/articles/PMC6139259/

2. Okoye C, Obialo-Ibeawuchi CM, Obajeun OA, Sarwar S, Tawfik C, Waleed MS, Wasim AU, Mohamoud I, Afolayan AY, Mbaezue RN. Early Diagnosis of Autism Spectrum Disorder: A Review and Analysis of the Risks and Benefits. Cureus. 2023 Aug 9;15(8):e43226. doi: 10.7759/cureus.43226. PMID: 37692637; PMCID: PMC10491411. https://pmc.ncbi.nlm.nih.gov/articles/PMC10491411/

3. Tirkey SS, Verma RK, et. all, Investigating the Effectiveness of Early Intervention Services for Children with Developmental Delays. Int J Acad Med Pharm 2023; 5 (5); 156-160 https://academicmed.org/Uploads/Volume5Issue5/33.%20%5B1523.%20JAMP_JESUS%20The%20Master%5D%20156-160.pdf

4. Autism Speaks. Study finds autism early intervention highly effective. 2009 Nov 29. https://www.autismspeaks.org/science-news/early-intervention-toddlers-autism-highly-effective-study-finds

5. Keehn B, Monahan P, Enneking B, Ryan T, Swigonski N, McNally Keehn R. Eye-Tracking Biomarkers and Autism Diagnosis in Primary Care. JAMA Netw Open. 2024 May 1;7(5):e2411190. doi: 10.1001/jamanetworkopen.2024.11190. PMID: 38743420; PMCID: PMC11094561. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2818669

6. Disability Scoop. FDA Approved Eye-Tracking Device May Speed Autism Diagnosis … 2023 Sep 7. https://www.disabilityscoop.com/2023/09/07/fda-approved-eye-tracking-device-may-speed-autism-diagnosis-studies-suggest/30536/

7. Chetcuti, L., Varcin, K.J., Boutrus, M. et al. Feasibility of a 2-minute eye-tracking protocol to support the early identification of autism. Sci Rep 14, 5117 (2024). https://doi.org/10.1038/s41598-024-55643-z https://www.nature.com/articles/s41598-024-55643-z

8. Zwaigenbaum L, Bauman ML, Stone WL, Yirmiya N, Estes A, Hansen RL, McPartland JC, Natowicz MR, Choueiri R, Fein D, Kasari C, Pierce K, Buie T, Carter A, Davis PA, Granpeesheh D, Mailloux Z, Newschaffer C, Robins D, Roley SS, Wagner S, Wetherby A. Early Identification of Autism Spectrum Disorder: Recommendations for Practice and Research. Pediatrics. 2015 Oct;136 Suppl 1(Suppl 1):S10-40. doi: 10.1542/peds.2014-3667C. PMID: 26430168; PMCID: PMC9923897. https://pmc.ncbi.nlm.nih.gov/articles/PMC9923897/

9. Goldstar Rehab. Uncovering The Negative Impact Of Late Autism Diagnosis. 2025 Feb 26. https://www.goldstarrehab.com/parent-resources/negative-effects-of-an-autism-diagnosis-later-in-life

10. Dream Big Children. Adverse Effects of an Autism Diagnosis Later in Life. 2023 Nov 13. https://dreambigchildren.com/blog/adverse-effects-of-an-autism-diagnosis-later-in-life-why-early-intervention-is-better/

11. Georgia Tech. Methods: Outcome Data Collection Objective Early intervention in… https://autism.gatech.edu/downloads/methods-intervention.pdf

12. ABTABA. Mastering Autism Therapy Progress Tracking. 2024 Jul 21. https://www.abtaba.com/blog/autism-therapy-progress-tracking

13. Pierce K, Gazestani VH, Bacon E, et al. Evaluation of the Diagnostic Stability of the Early Autism Spectrum Disorder Phenotype in the General Population Starting at 12 Months. JAMA Pediatr. 2019;173(6):578–587. doi:10.1001/jamapediatrics.2019.0624 https://jamanetwork.com/journals/jamapediatrics/fullarticle/2732144

14. Gabbay-Dizdar, N., Ilan, M., Meiri, G., Faroy, M., Michaelovski, A., Flusser, H., Menashe, I., Koller, J., Zachor, D. A., & Dinstein, I. (2021). Early diagnosis of autism in the community is associated with marked improvement in social symptoms within 1–2 years. Autism, 26(6), 1353-1363. https://doi.org/10.1177/13623613211049011 (Original work published 2022) https://journals.sagepub.com/doi/epub/10.1177/13623613211049011

15. Jones W, Klaiman C, Richardson S, et al. Eye-tracking–based measurement of social visual engagement compared with expert clinical diagnosis of autism. JAMA. 2023;330(9):854–865. https://jamanetwork.com/journals/jama/fullarticle/2808996

16. Jones W, Carr K, Klin A, et al. Development and replication of objective measurements of social visual engagement to aid early diagnosis and assessment of autism. JAMA Network Open. 2023;6(9):e2330145. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2808909

17. Randall M, Egberts KJ, Samtani A, Scholten RJPM, Hooft L, Livingstone N, Sterling-Levis K, Woolfenden S, Williams K. Diagnostic tests for autism spectrum disorder (ASD) in preschool children. Cochrane Database of Systematic Reviews 2018, Issue 7. Art. No.: CD009044. DOI: 10.1002/14651858.CD009044.pub2 https://pmc.ncbi.nlm.nih.gov/articles/PMC6513463/

18. Kalb LG, Singh V, Hong JS, Holingue C, Ludwig NN, Pfeiffer D, Reetzke R, Gross AL, Landa R. Analysis of Race and Sex Bias in the Autism Diagnostic Observation Schedule (ADOS-2). JAMA Netw Open. 2022 Apr 1;5(4):e229498. doi: 10.1001/jamanetworkopen.2022.9498. PMID: 35471566; PMCID: PMC9044110. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2791527