2014

Results from REGISTRY 1 Study Confirm Clinical Utility of Corus® CAD Genomic Test in Optimizing Care in Elderly Patients Presenting to the Primary Care Clinician with Symptoms Suggestive of Obstructive Coronary Artery Disease - Corus® CAD Gene Expression Test Impacts Clinical Decision-Making in Primary Care Practices and Reduces Unnecessary Referrals for Cardiac Testing in this Special Population -

PALO ALTO, Calif., Nov. 25, 2013 /PRNewswire/ -- CardioDx, Inc., a molecular diagnostics company specializing in cardiovascular genomics, announced results from a multi-center, real-world registry study highlighting the clinical utility of Corus® CAD in evaluating suspected obstructive coronary artery disease (CAD) in patients 65 years or older. The study was presented at the 66th Annual Scientific Meeting of The Gerontological Society of America (GSA), taking place November 20-24, 2013 in New Orleans, La.

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Corus CAD is the first and only commercially available blood-based gene expression test that provides a current-state assessment of obstructive CAD in non-diabetic patients presenting with typical or atypical symptoms. Corus CAD helps clinicians accurately rule out obstructive CAD as the cause of these symptoms.

"This real-world study shows how Corus CAD can be incorporated into everyday primary care practice as a tool to assess symptomatic patients early in the work-up for suspected obstructive CAD," said Joseph Ladapo, M.D., Ph.D., Assistant Professor of Medicine, Department of Population Health and Medicine, NYU School of Medicine. "The test's performance supports its use to rule out CAD as the cause of symptoms in elderly patients. Because the elderly are more susceptible to procedural complications and often face challenges and other unique burdens associated with follow-up testing, Corus CAD, a simple blood test, may be particularly beneficial in this population."

The Clinical Utility of a Novel Genomic-Based, Gene Expression Test to Evaluate Patients 65 Years or Older Presenting With Symptoms of Suspected Obstructive Coronary Artery Disease in the Ambulatory Care Setting, presented by Dr. Ladapo, was a subgroup analysis from a larger study and focused on 63 patients over the age of 65. This subgroup analysis showed that Corus CAD influenced clinical decision-making among primary care clinicians and was directly associated with a significant overall reduction in diagnostic test utilization among elderly patients with low scores (≤15). No patients with low Corus CAD scores were referred for further cardiovascular testing. In contrast, among patients with non-low scores (>15), 86% were referred for further testing. No major adverse cardiovascular events (MACE) were reported in patients with low or elevated Corus CAD scores in 30 day follow-up.1

"The advances made in individualized medicine have been noteworthy," said Mark Monane, M.D., Chief Medical Officer, CardioDx. "Genomic-based medicine empowers clinicians to tailor care for each patient and minimize a trial-and-error approach in evaluation as well as in treatment. Each person has a unique clinical, genomic and environmental history that impacts his or her health, and Corus CAD evaluates all of those factors through incorporating gene expression as well as age and gender to evaluate patients objectively and provide actionable information to help clinicians make more informed decisions for their patients. Through personalized medicine and precision diagnostics, the potential to transform healthcare for patients, clinicians and institutions is substantial."

About Obstructive Coronary Artery Disease

Coronary artery disease is a very common heart condition in the United States. One in six deaths among Americans is caused by CAD.2 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 Corus CAD

Corus CAD is a blood test that can safely, accurately and conveniently help primary care clinicians and cardiologists assess whether or not a stable non-diabetic patient's symptoms are due to obstructive CAD, enabling many patients to avoid unnecessary noninvasive and invasive cardiac procedures and exposure to imaging-related radiation risks, imaging agent intolerance 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 diagnosis 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.3,4 In the COMPASS study, Corus CAD outperformed MPI in diagnostic accuracy as a test to exclude obstructive CAD, 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 50,000 Corus CAD test results have been commercially delivered to clinicians. Corus CAD is a covered benefit for the estimated 48 million Medicare beneficiaries in the U.S. CardioDx processes all Corus CAD test samples at its CLIA-certified and CAP-accredited clinical laboratory in Palo Alto, Ca.

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 gene expression changes associated with atherosclerosis. Gene expression levels change depending on a person's disease status resulting from genetic and environmental factors.

About CardioDx

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.

Forward-Looking Statements

This press release may contain forward-looking statements, including statements regarding the safety, efficacy and the adoption rate 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 A MACE event is defined as cardiac death, nonfatal myocardial infarction, or target lesion revascularization.

2 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.

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.

4 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.

SOURCE CardioDx, Inc.



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http://www.cardiodx.com

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