Autism Clinical Trial
Official title:
SynapDx Autism Spectrum Disorder Gene Expression Analysis Study
This study will prospectively enroll approximately 660 children, at least 18 months and less
than 5 years of age, who have been referred to a pediatric developmental evaluation centers.
Enrolled children will have blood drawn for RNA gene expression analysis and undergo a
clinical evaluation to determine the presence or absence of a diagnosis of ASD.
The sequential co-primary objectives of this study are:
- To develop an algorithm to classify blood RNA gene expression patterns to maximize
agreement between the classification and a clinical assessment of presence or absence
of Autism Spectrum Disorders (ASD).
- To prospectively assess the clinical sensitivity and specificity of the blood RNA gene
expression classification algorithm (the SDX-002 test) in children referred to a
developmental evaluation clinic for a possible developmental disorder.
n/a
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