|By Marketwired .||
|July 7, 2014 07:00 AM EDT||
REDWOOD CITY, CA -- (Marketwired) -- 07/07/14 -- CardioDx, Inc., a molecular diagnostics company specializing in cardiovascular genomics, confirmed today that Aetna has established a clinical policy for the company's Corus® CAD gene expression test. With this decision, the Corus CAD gene expression test is eligible for coverage among Aetna and Coventry Health members. Aetna considers the Corus CAD gene expression test medically necessary for evaluation of non-diabetic adults with chest pain or anginal equivalent symptoms who have no history of obstructive coronary artery disease.
About Obstructive Coronary Artery Disease
Coronary artery disease (CAD) is a very common heart condition in the United States. One in six deaths among Americans is caused by CAD.(1) CAD can cause a narrowing or blockage of the coronary arteries (vessels to the heart that supply the heart with blood, oxygen, and nutrients), reducing blood flow to the heart muscle. This narrowing or blockage in the coronary arteries is often referred to as obstructive CAD, characterized by the presence of atherosclerosis, or plaque.
About the Corus CAD Test
Corus CAD is a blood test that can safely and conveniently help primary care clinicians and cardiologists assess whether or not a stable non-diabetic patient's symptoms are due to obstructive CAD. This enables many patients to avoid unnecessary noninvasive and invasive cardiac procedures and exposure to imaging-related radiation risks, reactions from imaging dyes or complications with cardiac catheterization. The test involves a routine blood draw that is conveniently administered in the clinician's office. The test is simple, convenient, and as a sex-specific test for the evaluation of obstructive CAD, accounts for critical biological differences between men and women.
The test has been clinically validated in independent patient cohorts, including two prospective, multicenter U.S. studies, PREDICT and COMPASS.(2,3) In the COMPASS study, Corus CAD outperformed myocardial perfusion imaging (MPI) as a diagnostic test to exclude obstructive CAD by demonstrating a significantly higher sensitivity (89% vs. 27%, p < 0.001) and a significantly higher negative predictive value (96% vs. 88%, p < 0.001) than MPI for assessing the presence of obstructive CAD. Over 55,000 Corus CAD test results have been commercially delivered to clinicians. Corus CAD is a covered benefit for the estimated 49 million Medicare beneficiaries in the U.S. CardioDx processes all Corus CAD test samples at its CLIA-certified and CAP-accredited clinical laboratory in Redwood City, California.
About Gene Expression
Corus CAD is a gene expression test, not a genetic test. Whereas genetic testing may inform on lifetime disease risk, the Corus CAD gene expression test provides a current-state assessment of obstructive CAD by looking at the expression of genes associated with atherosclerosis. Gene expression levels change depending on a person's disease status resulting from genetic and environmental factors.
CardioDx, Inc., a molecular diagnostics company specializing in cardiovascular genomics, 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 committed to expanding patient access and improving healthcare quality and efficiency through the commercialization of genomic technologies. For more information, please visit www.cardiodx.com.
This press release may contain forward-looking statements, including statements regarding the safety and efficacy of and the size of the market for Corus CAD and beliefs regarding the need for and value of gene expression diagnostics. These statements relate to future events and involve known and unknown risks, uncertainties and other factors that could cause actual levels of activity, performance or achievement to differ materially from those expressed or implied by these forward-looking statements. These statements reflect the views of CardioDx as of the date of this press release with respect to future events and, except as required by law, it undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this press release.
1. Go AS, Mozaffarian D, Roger VL, et al. Heart Disease and Stroke Statistics--2013 Update: A Report From the American Heart Association. Circulation. 2013;127:e6-e245.
2. Rosenberg S, Elashoff MR, Beineke P, et al. Multicenter Validation of the Diagnostic Accuracy of a Blood-Based Gene Expression Test for Assessing Obstructive Coronary Artery Disease in Nondiabetic Patients. Ann Intern Med. 2010;153:425-434.
3. Thomas GS, Voros S, McPherson JA, et al. A Blood-Based Gene Expression Test for Obstructive Coronary Artery Disease Tested in Symptomatic Nondiabetic Patients Referred for Myocardial Perfusion Imaging: The COMPASS Study. Circ Cardiovasc Genet. 2013;6:154-162.
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