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CardioDx CAD Dx passes another post-marketing test

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CardioDx is promoting yet another post-marketing study whose data may help the company's gene expression test for obstructive coronary artery disease reach more patients, better compete with the standard of care and also build vital market share.

Executives at the California-based 2012 Fierce 15 company say they wanted more data on Corus CAD's real-world use, building on its previous PREDICT validation trial as a result. The test has been on sale commercially since 2009 and won crucial Medicare reimbursement last fall. Chief Scientific Officer Steven Rosenberg told FierceMedicalDevices via email that the results from the latest study pointed in a number of positive directions.

"It demonstrates performance at least as good as that seen in the PREDICT study, but in the population the Corus CAD is indicated for," Rosenberg said, "It shows significantly higher performance for obstructive CAD than MPI, which is the most common non-invasive imaging test used in this regard."

A 431-patient clinical study of the blood diagnostic rated the test with a 96% negative predictive value and 89% high sensitivity, in assessing the condition in patients who were referred for stress testing with myocardial perfusion imaging (MPI). (Last November, CardioDx heralded similar results from another study using Corus CAD on 98 geriatric patients.) Details are published in the journal Circulation: Cardiovascular Genetics.

The blood test, conducted at 19 U.S. sites through multiple academic institutions, determined that using Corus CAD earlier in the diagnostic process better assessed the presence of coronary artery disease versus MPI. This might encourage doctors to cut back on invasive, more expensive cardiac tests by ruling out obstructive CAD sooner. In other words, determining a patient doesn't have obstructive CAD eliminates the need for diagnostic procedures such as coronary angiography or coronary CT angiography, the company explains.

Post-marketing studies are increasingly important in today's health care market, with the need to demonstrate the utility of a device or diagnostic in as most detailed a way possible. And it's not just boosting the standard of care; the Affordable Care Act means value matters, too, more than ever before. Success with this mission can help broaden market share and also increase the chance of private as well as government insurance coverage. Additionally, new post-marketing trials can also set the stage for expanded indications down the line.

- read the release
- here's the journal abstract

Special Report: CardioDx – 2012 Fierce 15

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