Eye-tracking (and EEG) tests for autism: what’s real, what’s promising, and what families should know
Can Eye Tracking or EEG Tests Diagnose Autism
In recent years, families have become aware of emerging technologies like eye tracking and electroencephalography (EEG) that aim to assist in diagnosing autism. These tools are promising because they offer objective measurements instead of relying solely on traditional clinical observation. It is important for families to understand what aspects are scientifically validated, what remains under research, and the actual capabilities and limitations of these tools in everyday clinical practice.
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What Eye Tracking Technology Can Do Today
The EarliPoint Evaluation, an eye-tracking tool, has received FDA approval to help clinicians diagnose and evaluate Autism Spectrum Disorder in young children aged 16 to 30 months. This approval indicates that the FDA has reviewed evidence demonstrating the device’s safety and effectiveness, confirming it is substantially equivalent to similar medical devices already available on the market.
The tool operates by having a child watch brief social scene videos while cameras track their gaze. The proprietary software analyzes this visual attention data to produce objective metrics, which clinicians can incorporate into a comprehensive assessment.
A peer-reviewed, published study in the Journal of the American Medical Association demonstrated that eye-tracking data could predict autism diagnoses made by experts in a large study involving toddlers referred for evaluation. The findings showed that eye-tracking results matched specialist diagnoses, with approximately 71% sensitivity and 81% specificity across all participants. For children definitively diagnosed by experts, sensitivity increased to 78%, and specificity to about 85%.
These data indicate that the eye tracking tool captures meaningful patterns associated with autism in toddlers. However, the test does not identify every child with autism, nor does it eliminate false positive results. That is why its use is described as aiding the clinician’s judgment rather than replacing clinical evaluation.
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What EEG Technology Can Do Today
Electroencephalography, or EEG, records electrical activity from the scalp and has been used in medicine for decades to assess conditions like epilepsy and seizure risk. EEG is also widely used in research on brain development. Some research teams are studying whether certain EEG patterns might help predict later autism outcomes, and the Autism Biomarkers Consortium for Clinical Trials has worked on EEG measures that could serve as biomarkers in future research.
However, EEG is not currently a clinically validated diagnostic test for autism. Systematic reviews of EEG research specifically for autism classification have concluded that existing EEG measures do not yet have the sensitivity or specificity needed to make a reliable diagnosis on their own in clinical practice. At this time, EEG findings remain part of research or adjunctive study, not a standard tool for diagnosing autism in individual children.
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Strengths and Limitations of These Technologies
For families and clinicians, there are reasons to be interested in these tools, but also important reasons to be cautious.
Eye-tracking assessments can provide objective data that may help clinicians and families understand patterns of social visual engagement in a young child. The FDA clearance and published research mean that this methodology has undergone formal evaluation within a defined age range and clinical setting.
At the same time, the eye-tracking tool does not work for all ages, does not make a diagnosis by itself, and may not be available in every community. The sensitivity and specificity figures from research reflect real-world uncertainty; there will be both false negatives and false positives.
EEG remains a promising research modality for revealing differences in neural patterns. No EEG-based biomarker has been shown to stand alone as a reliable diagnostic test for autism in clinical practice.
The current best practice for autism diagnosis remains a comprehensive clinical evaluation by experienced professionals using standardized behavioral assessments, developmental history, direct observation, and caregiver report. There is no single biomarker or device that can replace this broader assessment at this time.
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Bottom Line for Families
Eye tracking technology has entered clinical use as an FDA-cleared tool to support clinicians in diagnosing autism in young toddlers. Research shows that these measurements align reasonably well with expert diagnostic conclusions in specialty clinic settings.
EEG is a valuable research tool that can provide insight into brain activity, but it is not an established clinical diagnostic test for autism at this time.
No technology today can replace the value of a detailed clinical evaluation by professionals experienced in autism diagnosis and intervention planning.
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References
Food and Drug Administration. 2023. 510(k) Premarket Notification: EarliPoint System (K230337). U.S. Department of Health and Human Services. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230337
Jones, Warren, Ami Klin, Erin A. Stark, Jamie Munson, Michelle Smith, Julie Winter, Elizabeth Greenson, Sarah Chang, and Geraldine Dawson. 2023. “Eye-Tracking Measures of Social Visual Engagement as an Aid to Diagnosis of Autism Spectrum Disorder in Toddlers.” Journal of the American Medical Association 330 (13): 1249–1259. https://jamanetwork.com/journals/jama/fullarticle/2808996
Lau-Zurita, Paula, Manuel Gómez-Andrés, and Alejandro J. Fernández-Isabel. 2023. “Electroencephalography-Based Machine Learning Approaches for Autism Spectrum Disorder: A Systematic Review.” Frontiers in Psychiatry 14: 1132769. https://doi.org/10.3389/fpsyt.2023.1132769