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CardioDx Joins Duke, NHLBI Coronary Artery Disease Research Effort

NEW YORK (GenomeWeb News) – CardioDx today said that it has joined a research effort launched by Duke University and the National Heart Lung and Blood Institute aimed at determining alternative diagnostic strategies for assessment of patients with symptoms that suggest coronary artery disease.

The Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) trial is testing the comparative effectiveness of anatomical versus functional noninvasive diagnostic tests for the assessment of stable symptomatic patients with possible CAD. The PROMISE trial, which began in 2010, will follow patients for up to four years, or until the study ends, with a primary endpoint of major adverse cardiac events and secondary endpoints related to procedural costs and safety.

As part of the study, CardioDx will purify and isolate DNA and RNA samples using proprietary methods. It also will use its blood-based gene expression test, Corus CAD, to evaluate blood samples from an estimated 2,500 to 3,000 nondiabetic patients enrolled in the trial, with a goal of evaluating the ability of the test to predict major clinical cardiovascular events.

"This study will allow us to build on the results of the Corus CAD test as an aid in the assessment of CAD, as demonstrated in the PREDICT and COMPASS validation studies," David Levison, president and CEO of Palo Alto, Calif.-based CardioDx, said in a statement. "The findings of PROMISE also will help us determine the potential for developing a new test specifically focused on prognosis for CAD patients, which could involve the use of next-generation sequencing technologies to identify expression of genes predictive of future events."

CardioDx launched Corus CAD in June 2009 as a laboratory-developed test. The firm received Medicare coverage for the test this past summer.