FDA Validation of a Salivary miRNA Diagnostic Test for Autism Spectrum Disorder
Quadrant Saliva Study
What is the goal of the study?
The central aim of this project is to validate Clarifi ASD as an in-vitro diagnostic (IVD) for use within its intended use population, children at risk for the development of autism spectrum disorder (ASD). Clarifi ASD is designed as a diagnostic aid for use in the primary care and pediatric setting, providing pediatricians information to support the medical necessity and urgency of a referral for autism specific treatment services and/or a comprehensive evaluation. The primary goal of this work is to demonstrate that Clarifi ASD can accurately distinguish children with ASD from those without ASD but screen at-risk. We propose to measure the expression of salivary RNA profiles by collecting saliva from children with ASD and non-ASD at-risk children, including those with DD. This study will build upon NIH funded Phase I (R41MH111347) and Phase II (R42MH111347) research.
Who can participate in the study?
Please contact the study team listed below to learn more.