Roche's cardiac diagnostic assay cleared for additional indication

By Angela McDaniels

Seattle, Jan. 3 - Roche Diagnostics Corp. said its NT-proBNP Test has received clearance from the Food and Drug Administration to be used to assess the risk of cardiac events in people with stable coronary disease.

The assay is currently cleared by the FDA as an aid in the diagnosis of patients suspected of congestive heart failure and as a marker of risk for patients with acute coronary syndrome and congestive heart failure.

"This additional application for use of NT-proBNP provides significant opportunities to help patients and their physicians learn more about their cardiac status and their cardiac risk," chief medical officer Mike Samoszuk said in a company news release.

"Millions of people in the United States have a high risk of developing cardiac events because they have stable coronary artery disease. Since this is an early marker of cardiac involvement in these disease processes, once a person is identified to be at cardiac risk, they can work with their physician to determine the best treatment and therapy early on."

Indianapolis-based Roche Diagnostics said it recently moved to the No. 1 position worldwide in the cardiac marker market and that proBNP is the only natriuretic peptide test approved in the United States for cardiac risk stratification in people with coronary artery disease.

Roche Diagnostics is a division of Roche, which has headquarters in Basel, Switzerland, and develops pharmaceuticals and diagnostics.

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