The trial started in January 2020 at two sites, La Trobe University and Telethon Kids Institute in Australia. Gazefinder, with JVCKENWOOD's ASD assessment program, was used to assess children with a diagnosis of ASD and Typically Developing (TD) children, aged two to four years. Efficacy and safety were verified by comparing the Gazefinder assessment results with those of conventional diagnosis by community professionals, and results from behavioural ASD assessment completed by the research teams. Since sufficient results were obtained for over 200 children, this clinical trial was completed. In response to the results, JVCKENWOOD submitted an application for medical device approval to the Australian TGA for an ASD assessment tool that applies technology of the Gazefinder eye-tracking system.