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Biological and analytical stability of a peripheral blood gene expression score for obstructive coronary artery

Susan E Daniels1, Philip Beineke, Brian Rhees

  • 1CardioDx, Inc., 600 Saginaw Drive, Redwood City, CA, USA.

Journal of Cardiovascular Translational Research
|August 15, 2014
PubMed

Insights

A validated gene expression score (GES) accurately predicts obstructive coronary artery disease (CAD). The score demonstrates stability over time and across diverse patient populations, supporting its clinical utility for diagnosing CAD.

Area of Science:

  • Cardiovascular Medicine
  • Molecular Diagnostics
  • Genomics

Background:

  • Obstructive coronary artery disease (CAD) poses a significant health burden.
  • Accurate diagnostic tools for CAD are crucial for timely intervention.
  • Gene expression scores (GES) offer a promising avenue for molecular diagnostics.

Purpose of the Study:

  • To validate a gene expression score (GES) for obstructive coronary artery disease (CAD).
  • To assess the analytic stability and performance of the GES across different patient cohorts.
  • To evaluate the longitudinal changes in GES and their correlation with disease likelihood.

Main Methods:

  • Receiver-operating characteristics (ROC) analysis was performed on the GES using quantitative coronary angiography (QCA) or clinical reads.
  • The GES was evaluated in multicenter studies, including the Personalized Risk Evaluation and Diagnosis in the Coronary Tree (PREDICT) cohort.
  • Analytic stability was assessed by re-testing stored samples, and longitudinal changes were monitored in the Coronary Obstruction Detection by Molecular Personalized Gene Expression (COMPASS) study.

Main Results:

  • The GES demonstrated consistent performance (AUC=0.70) in the PREDICT cohort (N=1,502) compared to the original validation cohort (AUC=0.70, N=526).
  • Performance was similar across Caucasian (AUC=0.70) and non-Caucasian (AUC=0.72) patient groups.
  • The GES exhibited analytic stability over 5 years (mean score change from 20.3 to 19.8) and showed a slight increase over approximately 1 year in COMPASS study patients (from 15.9 to 17.3).

Conclusions:

  • The validated gene expression score (GES) is a reliable predictor of obstructive coronary artery disease (CAD).
  • The GES demonstrates analytic stability and consistent performance across diverse populations and over time.
  • The findings support the potential clinical utility of the GES for diagnosing and monitoring obstructive CAD.

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