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CardioDx Wins Medicare OK of Molecular Test for Heart Disease

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build up its sales force following the Medicare approval, Levison says. The company isn’t profitable, but it is well-financed for this push, as it pulled in a $60 million equity financing in May 2011. Its backers include J.P. Morgan, Longitude Capital, Acadia Woods Partners, Kleiner, Perkins, Caufield & Byers, Mohr Davidow Ventures, TPG Biotech, Intel Capital, Pappas Ventures, DAG Ventures, Asset Management Group and GE Capital.

Getting Medicare to reimburse for the test is an important step for CardioDx’s effort to get cardiologists to start adopting the test, but there are other hurdles still to clear, says Eric Topol, the chief academic officer at Scripps Health in San Diego, and the lead investigator of a CardioDx trial called Predict.

“Reimbursement is part of the story. Another big part will be about whether cardiologists are willing to change their normal operating procedures,” Topol says. “And I emphasize procedures,” he says, because many cardiologists have deeply ingrained habits for diagnosing coronary artery disease through invasive procedures.

Although molecular diagnostics have made headway in oncology in recent years, it hasn’t caught on as quickly in cardiology, Topol says. One other company, Brisbane, CA-based XDx, has won Medicare approval for a molecular diagnostic of a heart-related ailment, but it’s focused on determining whether patients aren’t rejecting a transplanted heart.

Topol says he likes the way the CardioDx test can save time and money by enabling patients to forgo certain invasive tests. “If it comes out with a low score, the confidence level you’ll not miss someone is high. You will have done someone a great favor by not putting them through a heart [catheterization] test,” Topol says.

Topol says he isn’t aware of any competitor with any test like CardioDx’s in the works, and there’s a lot of potential for such a test. But it can’t answer every question a cardiologist or primary care physician might have about a heart patient, and while it will enable some patients to avoid invasive tests, it won’t replace them. “This is a really nice alternative, but whether it will be widely embraced is hard to predict. Reimbursement has been an issue until now,” Topol says.

CardioDx’s Levison acknowledged a slew of other challenges ahead. Private insurers will want to see a steady stream of data to show the test is effective, and save them money on unnecessary procedures in the short-term and long-term. Doctors will continue to have questions about which patients are right for the test, and which aren’t. And since chest pain is such a widespread symptom that masses of primary care doctors see every day, CardioDx has to get the word out about its test to a lot more than just a couple thousand thought-leading physicians like Topol. The company has been “cautious and deliberate” to not over-promote the product, Levison says, but now CardioDx intends to get the word out a little more now that it has the validation of Medicare under its belt. “This is what we were looking for,” he says.

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