Eye Tracking Biomarker Accepted into FDA Biomarkers Qualification Program

To diagnose autism, pediatricians, psychiatrists, and psychologists use scientifically validated assessment tools that rely heavily on observing child behaviors, while giving heavy weight to parent concerns and observations. Autism manifests itself in a wide range (or “spectrum”) of characteristics, and there is no “lab test” to easily make a diagnosis. Parent/caregiver concerns are shared using questionnaires, which research has shown favor highly educated people and those who speak English as a first language. Biological “markers” would make diagnosis less subjective, open doors to more equitable access to screening, and help make decisions about treatment and progress less dependent on subjective questionnaires.

To help find a solution, the National Institutes of Health (NIH) has invested $60 million in the Autism Biomarkers Consortium for Clinical Trials (ABC-CT), with the goal of making scientific advancements and finding autism biomarkers that track brain function. Prior to 2022, the ABC-CT, which is led by Yale and includes the Duke Center for Autism, Harvard, UCLA, and the University of Washington, validated a biomarker based on electroencephalogram (EEG), which was accepted into the Food and Drug Administration Biomarkers Qualification Program. This year, another biomarker based on eye-tracking has been accepted — the Oculomotor Index (OMI), a calculation that captures differences in how children attend to social information.

Numerous research studies show that autistic children tend to spend less time looking at social scenes in general, and at faces specifically. The ABC-CT team sought to quantify this difference, and in doing so, potentially develop another biomarker of autism. Nearly 400 children across all ABC-CT sites, ages 6–11, participated in this most recent study, completing clinical assessments and watching several short, fun videos that included social scenes and faces. Scientists compared differences in attention when watching social scenes, specifically looking at the percentage of time participants spent looking at faces compared to the time they spent looking at any other area on the screen. The team published its findings, “The Autism Biomarkers Consortium for Clinical Trials: evaluation of a battery of candidate eye-tracking biomarkers for use in autism clinical trials,” in Molecular Autism in March 2022.

“The study found that autistic children spent less time looking to the faces across all social scenes compared to their non-autistic peers, and we developed a way to calculate that percentage,” explained Marika Coffman, PhD, a licensed psychologist and researcher on Duke ABC-CT Study team. “Finding objective ways to diagnose and measure progress is vital to developing new supports and therapies for autistic people who need or want these.”

The nationwide ABC-CT Study team is now working to validate the OMI biomarker with new families of children between the ages of 6–11 with and without an autism diagnosis