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Digital healthcare company BlinkLab (ASX:BB1) has tested the first patient in its US autism diagnostic study, which is geared at validating the company's Dx1 test as a diagnostic aid for clinicians.
BlinkLab states in its Wednesday (March 12) release that the study is the largest digital diagnostic trial for autism in the US, with its aim being to support the early detection of developmental conditions like autism.
The first patient test took place at PriMED Clinical Research in Dayton, Ohio. PriMED, a division of PriMED Physicians, is one of two clinical sites selected for the study’s initial phase, which is targeting 100 patients.
"Launching our US trial marks a very special and important moment for BlinkLab. Our mission has always been to connect fundamental neuroscience with clinical practice through accessible technology, thereby enhancing autism diagnostic evaluations and enabling early intervention for children,” said CEO and Co-founder Dr. Henk-Jan Boele.
According to BlinkLab, the American Academy of Pediatrics advises that all children be screened for autism at 18 to 24 months. This is to refrain from delays in diagnosis, as many children miss critical windows for early intervention.
Dx1’s goal is to address these delays by helping healthcare providers deliver faster and more reliable assessments. The smartphone-based platform uses artificial intelligence to measure sensory sensitivity.
“After extensive app and portal development, stimulus refinement, and testing in hundreds of children, we are very confident in our (Food and Drug Administration) study's potential," Boele added.
Results from the targeted 100 participant study are scheduled for release in the third quarter of 2025. The trial will proceed to the main study thereafter, which aims to test 750 to 900 children.
BlinkLab’s submission for FDA 510(k) clearance is anticipated in 2026.
In 2023, privately held EarliTec Diagnostics came up with a similar innovation for autism detection. The company's creation focuses more on social-visual engagement, evaluating a child’s looking behaviour.
Currently, BlinkLab is the only ASX-listed company focusing on providing autism detection services or applications.
