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CardioDx Continues Adoption, Coverage Push for Corus CAD

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Originally published Sept. 24.

Having conducted 30,000 Corus CAD tests to date, CardioDx has gathered sufficient clinical utility and cost-effectiveness data to begin reimbursement talks with private payors, CEO David Levison said at the UBS Global Life Sciences Conference in New York last week.

CardioDx is marketing Corus CAD as a molecular diagnostic that can help doctors gauge whether a non-diabetic patient's symptoms are due to obstructive coronary disease. The company's hope is that the test will help reduce the number of patients sent unnecessarily to catheterization labs, amounting to $4.5 billion annually in healthcare spending.

Based on the expression of 23 genes, the patient's age, and gender, Corus CAD yields a score of one through 40. For patients who receive a score below 15, CardioDx recommends doctors not refer them to cardiologists for additional costly and more invasive procedures. The test analyzes gene expression from patients' blood samples. Approximately 50 percent of patients tested on Corus CAD receive a low score.

According to Levison's presentation at the UBS conference, CardioDx runs around 11,000 tests per year. The test carries a list price of $1,195 and has a 96 percent negative predictive value in gauging whether patients have a low chance that their chest pains are due to a blockage in their heart.

Following the recent Medicare coverage of Corus CAD, CardioDx has been focusing on expanding the use of its test among doctors and growing payor coverage.

Medicare contractor Palmetto announced in August that Corus CAD, launched by CardioDx as a laboratory developed test in 2009, had met its criteria for clinical validity and clinical utility as a reasonable and necessary Medicare benefit. The decision makes the test a covered benefit for more than 40 million Medicare enrollees (PGx Reporter 8/15/2012).

Medicare's backing for the test will form the "foundation" of the company's reimbursement strategy with private payors, Levison said at the UBS conference. CardioDx last month completed a $58 million private equity financing round that it will use to support ongoing clinical utility and cost-effectiveness research that it hopes will help persuade private payors to join Palmetto in covering the test (PGx Reporter 8/29/2012).

The company has conducted a clinical utility study, called IMPACT, in which researchers at Vanderbilt University enrolled non-diabetic patients referred to cardiologists for evaluation of chest pain and symptoms that could indicated coronary artery disease. The study investigators compared the diagnostic strategies that cardiologists indicated they would take for 83 patients before and after the Corus CAD test was administered and found that doctors changed their treatment decisions – such as whether or not to use myocardial perfusion imaging, computed tomography angiography, and cardiac catheterization – in 58 percent of the cases.

For 32 patients for whom cardiologists decreased the number of tests they chose to administer, 29 patients, or 90 percent, had a low score by Corus CAD. During six months of follow-up for these patients, researchers observed no major adverse cardiovascular events for any low-scoring patient who had not received further testing. All of the 16 patients who received a Corus CAD score of greater than 15 received increased testing.

In the US, 3 million patients each year see a doctor for chest pain, but for 90 percent of these individuals their chest pain is not due to a blockage in the heart. By helping primary care physicians figure out which patients with chest pain to refer to cardiologists for additional testing, the Corus CAD test could reduce spending on myocardial perfusion imaging procedures by 46 percent and of invasive angiographies by 40 percent, Levison said at the meeting.

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