CardioDx Announces Final Endpoint Results from the PRESET Registry at the AHA Scientific Sessions 2016

REDWOOD CITY, CA--(Marketwired - Nov 14, 2016) - CardioDx, Inc., a molecular diagnostics company specializing in cardiovascular genomics, announced results from the final endpoint analysis of the multi-center, community-based patient registry called the PRESET Registry (NCT01677156, A Registry to Evaluate Patterns of Care Associated with the Use of Corus CAD in Real World Clinical Care Settings). This analysis showed that the age, sex, and gene expression score (ASGES) derived from the Corus CAD blood test has clinical utility in the evaluation of outpatients presenting with stable symptoms suggestive of obstructive* coronary artery disease (CAD). Clinicians referred 10% of patients with low Corus CAD test scores (predefined as scores ≤ 15) versus 44% of patients with elevated scores (predefined as scores > 15) for further evaluation by cardiology or advanced cardiac testing (unadjusted Odds Ratio (OR) = 0.15, p < 0.0001; adjusted OR after accounting for clinical covariates = 0.18, p < 0.001.) Major adverse events and revascularization were noted in 3/252 (1.2%) patients with low Corus CAD scores and 14/314 (4.5%) patients with elevated Corus CAD scores (p < 0.03). The data was presented at the American Heart Association Scientific Sessions 2016, which took place on November 12-16 in New Orleans, La.

The Corus CAD blood test integrates age, sex, and gene expression levels into a single score corresponding to the current likelihood of a blockage or significant narrowing in the coronary arteries. The test has previously shown clinical validity in the COMPASS study, in which the Corus CAD test outperformed myocardial perfusion imaging (MPI) as a diagnostic tool to exclude obstructive CAD by demonstrating a higher negative predictive value (96% vs. 88%, p < 0.001) than MPI for evaluating the presence of obstructive CAD.¹ 

"The use of the age, sex, and gene expression score proved to be a valuable tool to identify a safe and effective course of care for those patients presenting with symptoms suggestive of obstructive CAD," said Joseph A. Ladapo, M.D., Ph.D., Assistant Professor of Medicine, Division of General Internal Medicine and Health Services Research, David Geffen School of Medicine at UCLA and lead author of the study. "Integrating the test into our approach for managing stable, symptomatic patients suspected of having obstructive CAD can help physicians provide effective and informative care for patients without exposing them to the risks of radiation or contrast dye associated with other, commonly used tests."