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New Study Concludes CardioDx Gene Expression Test is Cost Effectivefor Assessing Patients with Suspected Coronary Artery Disease

Results Presented at the 34th Annual Meeting of the Society for Medical Decision Making

PALO ALTO, Calif. – Oct. 23, 2012 – CardioDx, Inc., a pioneer in the field of cardiovascular genomic diagnostics, today announced results from a new health economics study of the use of the Corus® CAD gene expression test. Data presented at the 34th Annual Meeting of the Society for Medical Decision Making in Phoenix, Ariz., show that using Corus CAD as a first-line test prior to invasive or non-invasive imaging offers a cost-effective strategy for assessing nondiabetic patients presenting with symptoms suggestive of coronary artery disease (CAD).

The study found that using Corus CAD as a means of identifying patients who need no referral versus those who need referral to myocardial perfusion imaging (MPI) or invasive coronary angiography (ICA) is cost effective at $72,202 per quality adjusted life year (QALY) gained in a patient cohort closely resembling the commercial intended population for Corus CAD. This strategy represents a more efficient use of healthcare resources than the current usual care pathway involving MPI testing prior to invasive coronary angiography as a means for assessing obstructive coronary artery disease. Medical treatments in the United States are typically considered cost effective at less than $100,000 per QALY gained.

“This study addresses a large area of inefficiency in the health care system today. Although there are three million office visits each year for patients presenting to primary care with symptoms suggestive of CAD, only 10 percent of these patients ultimately receive a diagnosis of stable obstructive CAD – resulting in up to $5 billion in direct medical costs for potentially unnecessary cardiac imaging procedures,” said Charles E. Phelps, Ph.D., lead author of the study and professor emeritus of Economics at the University of Rochester in Rochester, N.Y. “The results show that the Corus CAD test is more cost-effective in assessing stable symptomatic patients for CAD than the current usual-care approach.”

“Corus CAD’s strong performance profile, particularly the test’s 96 percent negative predictive value, enables a clinician to confidently exclude patients without obstructive CAD prior to invasive or noninvasive imaging. The test is not only safe and convenient, it provides much-needed improvements in health care resource utilization while reducing unnecessary cardiovascular procedures and preventing unneeded radiation exposure for patients,” said David Levison, president and CEO of CardioDx.

The study was conducted using a Markov model to simulate the assessment of patients with symptoms suggestive of obstructive coronary artery disease. Costs and benefits of diagnosis and treatment strategies were tracked over the lifetime of a cohort of adults. The study compared the use of Corus CAD to identify patients who need referral to MPI or invasive angiography to the current usual-care strategy of employing MPI alone.

About Corus CAD
With a simple blood draw, Corus CAD can safely, accurately and conveniently help primary care clinicians and cardiologists assess whether or not a stable nondiabetic patient’s symptoms are due to obstructive coronary artery disease, enabling many patients to avoid unnecessary invasive procedures and exposure to imaging-related radiation risks or imaging agent intolerance. The test has been clinically validated in multiple independent patient cohorts, including two prospective, multicenter U.S. studies, PREDICT and COMPASS. 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 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.

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 nondiabetic 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.

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.


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Media Contact: Nicole Osmer
650.454.0504
nicole@nicoleosmer.com