PALO ALTO, Calif.--(BUSINESS WIRE)--CardioDx, a pioneer in the field of cardiovascular genomic diagnostics, today announced that data presented at the American College of Cardiology’s 60th Annual Scientific Sessions demonstrate the ability of Corus™ CAD, a blood-based gene expression test, to identify obstructive coronary stenosis while adding independent information to coronary calcium scoring in patients undergoing CT angiography. In this study, the negative predictive value of Corus CAD for identifying obstructive coronary artery disease as assessed by CT angiography exceeded 95%.
“The results of this independent cohort provide new support for the high negative predictive value of the Corus CAD test in the identification of obstructive coronary artery disease in stable patients being noninvasively assessed,” said Szilard Voros, M.D., of The Piedmont Heart Institute Physicians group in Atlanta, the investigator who presented the results. “The ability of gene expression testing to provide independent information to a noninvasive imaging modality like coronary calcium scoring can empower more comprehensive decision-making about patient management.”
This study utilized data from the multi-center, prospective PREDICT trial (Personalized Risk Evaluation and Diagnosis In the Coronary Tree) originally published in October 2010 in the Annals of Internal Medicine, the journal of the American College of Physicians. Original findings from the PREDICT trial validated the ability of Corus CAD to help clinicians confidently identify whether or not obstructive CAD is causing patient symptoms. The original findings demonstrated that Corus CAD can accurately assess obstructive coronary disease as measured by quantitative coronary angiography (QCA). The current study extends these data to include obstructive coronary artery disease as measured by coronary CT angiography.
“CardioDx is focused on broadening the Corus CAD clinical evidence base for physicians and payers,” said David Levison, chief executive officer of CardioDx. “We believe these data reinforce the strong performance and clinical utility of Corus CAD for primary care and cardiology clinicians evaluating stable patients with symptoms suggestive of coronary artery disease.”
A study published in the March 11, 2010 issue of the New England Journal of Medicine found that in nearly 400,000 patients who underwent elective invasive angiographic procedures, 62% were found to have no obstructive coronary artery blockage. As in the PREDICT trial, this study enrolled patients with suspected coronary artery disease. The study authors concluded that current modalities for identifying which patients should undergo elective invasive coronary angiography to diagnose coronary artery disease have limitations, and that better methods are needed for patient risk stratification. Similarly, the PREDICT study found that 63% of patients enrolled had no obstructive coronary artery disease.
About Corus CAD
Corus CAD is the first and only clinically validated blood-based test for obstructive coronary artery disease. The test involves a routine blood draw conveniently administered in the clinician’s office and does not expose patients to risks of radiation or imaging agent intolerance. Corus CAD is a decision-making tool that can help primary care clinicians and cardiologists evaluate whether a non-diabetic patient's symptoms are due to obstructive coronary artery disease. It is the first sex-specific test for obstructive coronary artery disease, accounting for critical biological differences between men and women.
The test has been honored as a winner of the Wall Street Journal’s prestigious Technology Innovation Awards and one of TIME Magazine’s Top Ten Medical Breakthroughs for 2010.
The Corus CAD test procedure uses the RNA levels of 23 genes. Because the RNA levels are increased or decreased when obstructive coronary artery disease is present, Corus CAD is able to measure the likelihood that an individual patient has obstructive coronary artery disease from a simple blood sample.
Corus CAD is commercially available through an innovative patient sample kit that includes everything needed for blood collection and express delivery to the company’s CLIA-certified Palo Alto, Calif. laboratory. Test results are delivered promptly to the clinician’s office. Corus CAD is currently available in the United States.
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About Gene Expression Testing
Gene expression testing provides valuable tissue and cell-specific information about the molecular mechanisms involved in disease processes, enabling evaluation of an individual patient’s disease state, activity, and/or progression at a given point in time. Unlike genetic tests, which measure genetic variations, mutations, traits and predispositions – factors that are constant over a person’s lifetime – gene expression testing assesses a dynamic process, integrating both genetic predisposition and additional behavioral and environmental influences on current disease state.
About CardioDx
CardioDx, Inc., a pioneer in the field of cardiovascular genomic diagnostics, is committed to developing clinically validated tests that empower clinicians to better tailor care to each individual patient. Strategically focused on coronary artery disease, cardiac arrhythmia and heart failure, CardioDx is poised to expand patient access and improve healthcare quality and efficiency through the commercialization of genomic technologies. For more information, please visit www.cardiodx.com.