STORY

Study Name: SynapDx Autism Spectrum Disorder Gene Expression Analysis (STORY) Study

PI: Linmarie Sikich
Sponsor
: SynapDx Corperation
Contact person:
Lindsey Hazzard
Phone:
1-800-708-0048
E-mail:
ASPIRE@unc.edu

Overview

The purpose of this study is to develop an algorithm to classify blood RNA gene expression patterns in such a way as to maximize agreement between the classification and a clinical assessment of the presence or absence of Autism Spectrum Disorder (ASD). In addition, this study hopes to 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. Participants must not have had a prior diagnosis of autism spectrum disorder. Participants will complete a diagnostic evaluation and language assessments, and a blood sample will be taken for analysis. There are no treatments involved in this study.

Subject Payment

Participants will be provided with free and convenient parking. Research related services will be free of charge, and participants will be compensated $75 per visit.

Major Inclusion Criteria

  • Participants are referred to ASPIRE for evaluation of a possible developmental disorder, other than isolated motor problems
  • Participants are 1½ - 4 years of age at the time of informed consent

Major Exclusion Criteria

  • Participants have a prior reliably established diagnosis of Autism Spectrum Disorder from a clinic specialized in pediatric developmental evaluation

Target enrollment

50 at site (660 total)

Date enrollment closes

TBD

 

Study Related Resources