CardioDx and Core Diagnostics India Announce Exclusive Corus® CAD Product Marketing and Sales Agreement

PALO ALTO, Calif., April 25, 2013 /PRNewswire/ -- CardioDx, Inc., a pioneer in the field of cardiovascular genomic diagnostics, today announced it has entered into an agreement granting to Core Diagnostics India the exclusive right to market and sell CardioDx's Corus^® CAD diagnostic test in India. Corus CAD is a noninvasive blood-based gene expression test for the assessment of patients with signs and symptoms suggestive of obstructive coronary artery disease (CAD).

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Corus CAD requires just a simple blood draw to conveniently, safely, and reliably help clinicians evaluate the presence of obstructive CAD in stable non-diabetic patients early in the diagnostic pathway. Corus CAD has the potential to reduce patients' exposure to unnecessary invasive and noninvasive procedures.

Under the agreement, Core Diagnostics will make Corus CAD available to patients in India, which has one of the highest rates of CAD[1] in the world and where over 15 billion USD is spent annually on out-of-pocket health care expenses[2]. Blood samples collected from patients in India for Corus CAD testing will be sent overnight to CardioDx's CLIA-certified laboratory in Palo Alto, California for rapid analysis and turnaround.

"We are very excited about our agreement with Core Diagnostics that will expand the reach of Corus CAD to India and provide those patients with a safe and reliable alternative to traditional imaging and invasive testing methods, which may expose patients to radiation, imaging agent intolerance and other procedure-related risks and complications," said David Levison, President and Chief Executive Officer of CardioDx. "Core Diagnostics is an innovative leader at the forefront of advanced diagnostic testing in India and an ideal marketing partner for CardioDx."

Gurgaon-based Core Diagnostics India offers a comprehensive menu of specialized, advanced diagnostic testing in India in the areas of cardiology, oncology, reproductive disorders, endocrinology and infectious diseases. The company provides patients with peace of mind by delivering second opinions on all cases by at least two specialists from a global panel of pathologists.

"Molecular, genomic and proteomic based diagnostics will play a crucial role in disease stratification, and in objectively selecting the best treatment path," said Gurpreet Singh Wander, MD, DM, Professor and Chief Cardiologist of Hero DMC Heart Institute, Ludhiana. "CadCORE, based on the Corus CAD test, marks a significant step in that direction."

Core Diagnostics India is working with physicians from prominent medical centers in the U.S. to collaborate with their Indian colleagues. The company deploys next generation sequencing in clinical applications and uses digital pathology for enabling concurrent global review of test results.

"Coronary artery disease is a rising epidemic in India and about 62 million of the country's population is estimated to suffer from CAD by 2015," said Mohan Uttarwar, Chief Executive Officer of Core Diagnostics. "CardioDx's state-of-the-art Corus CAD gene expression diagnostic test will help us spearhead the personalized medicine movement in India and provide diagnostic technology that is more convenient than current diagnostic tests for CAD. Corus CAD helps physicians accurately and easily determine early in the assessment process whether their patients' symptoms are due to obstructive CAD. This test will help meet the needs of a new generation of patients in India who insist on individualized, best-in-class medical care."

Core Diagnostics is backed by Palo Alto, California-based Artiman Ventures. Artiman Ventures is also an investor in CardioDx.

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.

About Core Diagnostics

Core Diagnostics is a clinical laboratory focused on next generation diagnostics for disease stratification and therapy selection. The company focuses on bringing the most advanced testing techniques and expertise to India. Core Diagnostics aims to become the destination for all of India's high-end diagnostic needs.

CORE Diagnostics is truly one of a kind, because of:

• Rich menu of high-end tests
• Second opinion on every test from a global panel of pathologists
• Very short turnaround time

The company's initial test offerings are in the areas of cardiology, oncology, reproductive disorders, endocrinology, and infectious diseases. For more information, please visit www.corediagnostics.in.

About Corus CAD

Corus CAD is the only clinically validated blood-based test for the assessment of 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. It is the only sex-specific test for obstructive coronary artery disease, accounting for critical biological differences between men and women.

The test has been clinically validated in multiple independent patient cohorts, including two prospective, multicenter U.S. studies, PREDICT and COMPASS. In the COMPASS study, Corus CAD was superior to MPI in diagnostic accuracy, sensitivity (89 percent vs. 27 percent, p<0.001) and negative predictive value (96 percent vs. 88 percent, p<0.001) and demonstrated excellent performance for excluding obstructive coronary artery disease relative to both invasive angiography and CTA.[3] Additionally, a retrospective, multicenter chart review study and the prospective IMPACT trial at Vanderbilt University demonstrated that Corus CAD use yields statistically significant and clinically relevant changes in patient management decisions in both primary care and cardiology settings.

Corus CAD has also been recognized by The Wall Street Journal's Technology Innovation Awards, honored as a Gold Edison Award recipient, and named one of TIME's Top Ten Medical Breakthroughs. CardioDx was recently honored as one of FierceMedicalDevices' "Fierce 15" most promising privately held medical device and diagnostic companies.

The Corus CAD test is intended for use in non-diabetic stable patients who present with typical or atypical symptoms suggestive of CAD, with no known history of CAD, no prior myocardial infarction (MI) or revascularization procedure, and who are not currently taking steroids, immunosuppressive agents or chemotherapeutic agents.

Corus CAD has been used commercially by clinicians in more than 35,000 patients and is a covered benefit for more than 40 million Medicare enrollees in the U.S.

CardioDx Forward-Looking Statements

This press release may contain forward-looking statements, including statements regarding the safety and efficacy, adoption rate and size of the market for Corus CAD, the potential results and outcomes of the agreement with Core Diagnostics India, 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] Enas EA, Singh V, Munjal YP, et al. Reducing the burden of coronary artery disease in India: challenges and opportunities. Indian Heart J. 2008; 60(2):161-75.

[2] Engelgau MM, Karan A, Mahal A. The Economic Impact of Non-Communicable Diseases on Households in India. Globalization and Health. 2012;8:9.

[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.

SOURCE CardioDx, Inc.