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CardioDx Completes Validation Study of First-Of-Its-Kind Genomic Test for Coronary Artery Disease

Friday, September 18, 2009 General News J E 4
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PALO ALTO, Calif., Aug. 25 CardioDx, a cardiovascular genomic diagnostics company, announced today that the company has successfully completed its multicenter validation study for Corus(TM) CAD, the first and only gene expression test to quantify the likelihood of obstructive(1) coronary artery disease (CAD) in patients with stable chest pain. The company expects to present results of the study by the end of 2009, and will publish the results in 2010.

Following completion of the validation study, CardioDx has made Corus CAD available in nine states initially, with broader availability expected in 2010. The test is now available in Kentucky, Maryland, Illinois, Washington, Wisconsin, Minnesota, North Carolina, Texas and Arizona. Patient samples are processed in Palo Alto at CardioDx's CLIA-certified laboratory.

"Completing the validation study for Corus CAD marks a major milestone for CardioDx," said David Levison, chief executive officer of CardioDx. "Our focus now turns to further developing the clinical and economic evidence needed to increase patient access to the unique benefits of Corus CAD."

Currently, the presence of obstructive CAD in patients with stable chest pain is most often evaluated through functional and/or anatomical assessment of the heart and its vessels, including stress echocardiography, myocardial perfusion imaging, and computed tomography angiography. However, despite advances in imaging technology, these techniques can be subjective and challenging for cardiologists, because of variation in presenting symptoms and each patient's unique disease characteristics. Corus CAD provides unique genomic information about an individual's disease processes at the molecular and cellular levels. When this information is combined with standard clinical assessments, physicians obtain a more complete picture of their patient's disease and can better individualize patient care.

"Our decision to develop Corus CAD was derived from many physician interactions in which they stressed the importance of and current challenges with effectively assessing obstructive CAD in patients with stable chest pain," said Levison. "We envision that a non-invasive, objective, easy-to-use test such as Corus CAD will empower physicians to more confidently identify which of these patients may have obstructive CAD."

About Corus CAD

Corus CAD is a clinically validated genomic test that integrates the expression levels of 23 genes and other patient characteristics to assess obstructive CAD. The test is intended to be used in an outpatient setting with clinically stable, non-diabetic patients who present with chest pain or who have a high risk of coronary artery disease, but without previously diagnosed myocardial infarction (heart attack) or prior revascularization procedure. Corus CAD is convenient and safe, and only requires a standard blood draw procedure. The test yields an objective result delivered to the physician in the form of a numeric score that quantifies the likelihood that a patient with stable chest pain has obstructive CAD.

Clinical Data

CardioDx designed a rigorous scientific plan and a prospective, nationwide, multi-center clinical study, PREDICT (Personalized Risk Evaluation and Diagnosis in the Coronary Tree, www.clinicaltrials.gov) to develop and validate Corus CAD. The PREDICT study sought to determine whether a gene expression test could be developed to identify obstructive CAD in patients with stable chest pain. The company has collected more than 2,800 patient samples in PREDICT from more than 40 clinical sites in the United States as of April 2009. Trial results and the Corus CAD validation data are expected to be presented toward the end of 2009.

About Obstructive CAD

Cardiovascular disease affects tens of millions of Americans each year and is the leading cause of death in the United States. Coronary artery disease (CAD) is a narrowing or blockage of the coronary arteries (the major blood vessels that supply the heart with blood, oxygen and nutrients) that reduces blood flow to the heart muscle. As a result of the blockage, the heart does not get enough oxygenated blood, which can often cause chest pain (angina), shortness of breath and other symptoms. A severe blockage can cause a heart attack (myocardial infarction) or even death; one of every five deaths among Americans is caused by CAD. In 2008, CAD had an estimated direct and indirect cost of over $165 billion.

About CardioDx

CardioDx is a cardiovascular genomic diagnostics company providing physicians with clinically validated tests to enable more informed and individualized patient care decisions. We are strategically focused on developing products for three forms of cardiovascular disease: coronary artery disease (CAD), cardiac arrhythmias and heart failure. The company's first product, Corus(TM) CAD, is the first and only gene expression test to quantify the likelihood of obstructive coronary artery disease in a stable chest pain patient. Developed and validated in a multicenter U.S. clinical trial, Corus CAD integrates the activity of a panel of genes with other patient characteristics to assess obstructive coronary artery disease. Corus CAD is now available in nine states - Kentucky, Maryland, Illinois, Washington, Wisconsin, Minnesota, North Carolina, Texas and Arizona - via the CardioDx CLIA-certified Commercial Laboratory with broader availability expected in 2010. CardioDx was founded in 2004 and is located in Palo Alto, California. For more information, please visit www.cardiodx.com.

(1) Obstructive CAD is defined as at least one atherosclerotic plaque causing greater than or equal to 50% luminal diameter stenosis in a major coronary artery (greater than or equal to 1.5mm lumen diameter) as determined by invasive quantitative coronary angiography (QCA).

SOURCE CardioDx
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