SOURCE: CardioDx

CardioDx

April 09, 2014 08:00 ET

CardioDx and Medison Israel Enter Into an Exclusive Corus® CAD Product Marketing and Sales Agreement

Agreement Will Provide Patients in Israel With Access to the Only Clinically Validated Gene Expression Test for the Assessment of Obstructive Coronary Artery Disease

PALO ALTO, CA and PETACH TIKVA, ISRAEL--(Marketwired - Apr 9, 2014) - CardioDx, Inc. and Medison today announced they have entered into an agreement granting Medison Israel the exclusive right to market and sell CardioDx's Corus® CAD blood-based genomic diagnostic test for the assessment of obstructive coronary artery disease (CAD) in Israel.

Corus CAD is the first and only commercially available gene expression test that provides a current-state assessment of obstructive CAD in non-diabetic patients presenting with typical or atypical symptoms. It is the only sex-specific test for the diagnosis of obstructive CAD that accounts for critical biological differences between men and women. Corus CAD helps clinicians more accurately determine early in the diagnostic work-up whether or not their patient's symptoms are due to obstructive CAD.

Under the agreement, Medison will make Corus CAD available to patients in Israel, where heart disease is the second leading cause of mortality and is responsible for approximately 16% of all deaths each year.1 Blood samples collected from patients in Israel for Corus CAD testing will be sent to CardioDx's CLIA-certified laboratory in Palo Alto, California, for rapid analysis and test reporting.

"We look forward to the positive impact that the Corus CAD test will bring to patients in Israel through our collaboration with Medison. Corus CAD will provide a safe, reliable, and convenient alternative to the traditional methods of noninvasive and invasive testing that expose patients to procedural risks and complications," said David Levison, President and Chief Executive Officer of CardioDx. "With more than three generations of healthcare expertise, Medison is an ideal partner for CardioDx to enable patient access to Corus CAD in Israel."

Based in Petach Tikva, Medison delivers innovative healthcare solutions in the areas of cardiology, human genetics, neurology, oncology, gastroenterology, nephrology, hematology, endocrinology, infectious diseases, and allergology. With its long-standing relationships with health maintenance organizations, medical centers, and physicians, Medison is working with physicians within Israel to provide individualized treatments for their patients.

The company has been active within the cardiology field for more than a decade and has extensive experience in obstructive CAD.

"Instead of relying on cardiac procedures that come with significant costs and significant risks of complications, Corus CAD allows us to use precision medicine for the initial assessment of obstructive CAD," said Meir Jakobsohn, Founder and CEO of Medison. "Using a noninvasive genomic test to accurately and easily determine whether or not a patient's symptoms are due to obstructive CAD will allow clinicians to provide both a more patient-centered approach to care and optimize use of healthcare resources."

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 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 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, Calif.

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

About Medison

Medison is Israel's leading market group, representing innovative niche healthcare products from companies such as Lantheus Medical Imaging, The Medicines Company, Cepheid, Carl Zeiss, Biogen Idec, Amgen, Shire and Ipsen. Backed by three generations of experience in the healthcare industry since 1937, Medison is uniquely qualified to provide the complete spectrum of integrated services for international companies looking to enter or expand their presence in the Israeli market. Medison has an office in Petach Tikva, Israel and is very active also in Romania.

Forward-Looking Statements

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 Israeli Central Bureau of Statistics. "Israel in Figures 2012." Available at: http://www.cbs.gov.il/www/publications/isr_in_n12e.pdf 
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.
3 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.

Contact Information

  • For media inquiries in the U.S., please contact
    Mai Duong
    Lazar Partners
    +1-646-871-8492
    mduong@lazarpartners.com.

    For media inquiries in Israel, please contact
    Eva Tavor
    Medison
    972-3-9250245
    eva@medison.co.il