![]() These include greater improvements in social and communication skills 2, 3, cognitive abilities 4, 5, verbal abilities 3, 6, and adaptive behavior 7, 8. The importance of timely ASD diagnosis, possible as early as 18 months, is underscored by studies linking earlier intervention during the critical neurodevelopmental window to enhanced long-term outcomes. Similar content being viewed by othersĪutism spectrum disorder (ASD) is one of the most common developmental disorders, with a US prevalence of 1.9% 1. The Device shows promise to significantly increase the number of children able to be diagnosed with ASD in a primary care setting, potentially facilitating earlier intervention and more efficient use of specialist resources. For nearly a third of this primary care sample, the Device enabled timely diagnostic evaluation with a high degree of accuracy. No significant differences in Device performance were found across participants’ sex, race/ethnicity, income, or education level. Among participants for whom the Device abstained from providing a result, specialists identified that 91% had one or more complex neurodevelopmental disorders. If this risk control measure were removed, the sensitivity for all study completers would fall to 51.6% (63/122) (95% CI 42.4%, 60.8%), and specificity would fall to 18.5% (56/303) (95% CI 14.3%, 23.3%). ![]() The Device’s indeterminate output acts as a risk control measure when inputs are insufficiently granular to make a determinate recommendation with confidence. For the 31.8% of participants who received a determinate output (ASD positive or negative) Device sensitivity was 98.4% (91.6%–100%) and specificity was 78.9% (67.6%–87.7%). This study compared Device outputs to diagnostic agreement by two or more independent specialists in a cohort of 18–72-month-olds with developmental delay concerns (425 study completers, 36% female, 29% ASD prevalence). ![]() ![]() The Device combines behavioral features from three distinct inputs (a caregiver questionnaire, analysis of two short home videos, and an HCP questionnaire) in a gradient boosted decision tree machine learning algorithm to produce either an ASD positive, ASD negative, or indeterminate output. This double-blinded, multi-site, prospective, active comparator cohort study tested the accuracy of an artificial intelligence-based Software as a Medical Device designed to aid primary care healthcare providers (HCPs) in diagnosing ASD. Autism spectrum disorder (ASD) can be reliably diagnosed at 18 months, yet significant diagnostic delays persist in the United States. ![]()
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