CardioDx Wins Medicare OK of Molecular Test for Heart Disease

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CardioDx has spent three years marketing a new genetic test that can tell when a patient’s chest pain is a sign of serious heart disease, or no big cause for alarm. It still has a long way to go before becoming part of mainstream medicine, but now the company has taken a big step ahead by persuading Medicare, the agency that provides health insurance to Americans over age 65, that its test is worth the money.

Palo Alto, CA-based CardioDx is announcing today that Palmetto GBA, the national contractor for Medicare, has agreed to reimburse the company for its Corus CAD test. CardioDx isn’t saying how much Medicare agreed to pay for the test, but it sells for a list price of $1,195 per patient, CEO David Levison says. The decision effectively means that more than 40 million Medicare patients are eligible for the test, as long as their doctor prescribes it.

The CardioDx test, which I wrote about here in November, is attempting to blaze a new trail for molecular diagnostics for heart disease. The Corus CAD test takes a blood sample from a patient, analyzes the extent to which RNA from 23 genes is expressed in the blood, and that says in 72 hours whether a patient is at low risk of coronary artery disease. By using this kind of molecular diagnostic test in patients in non-emergency situations, CardioDx is hoping to help patients and doctors avoid some of the costly and invasive procedures currently used to suss out whether chest pain symptoms are a sign of a larger problem or not.

CardioDx CEO David Levison

CardioDx has been marketing this test since June 2009 in a pretty limited way until now. The company has performed the test 30,000 times through a mixture of free offerings, patients paying for it out of their own pockets, or by case-by-case negotiations with private insurers, which Levison calls “hand-to-hand combat.” Winning Medicare reimbursement is a big step in smoothing out that process, which is important, because Medicare is the largest insurer of patients likely to demand the CardioDx product. It’s also important because Medicare’s actions are influential with private insurers.

“This is a very important milestone for the growth of the company. It clearly says our data package is sufficient for a major national payer to reimburse for it for tens of millions of covered lives,” Levison says. “It says the test has clinical utility, and is economically viable. We’ll leverage it.”

The market for a new coronary diagnostic like this is huge, although largely untapped. Heart disease is the leading cause of death in the U.S., and millions of people worry and wonder about whether they’ve got it every year. An estimated 9.2 million people underwent the current standard myocardial perfusion imaging tests in 2005, usually after reporting chest pain, CardioDx says. Those tests typically cost about $800, and take about three hours to yield results. Last November, CardioDx released clinical results that showed its test was better at determining when patients complaining of chest pain don’t have coronary artery disease. The hope is that if doctors feel confident enough to rely on that kind of finding, they could help patients and insurers avoid costly and invasive catheter-based procedures.

CardioDx has fewer than 100 employees today, and a small sales force of 10, although it expects to … Next Page »

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