Healthcare Industry News:  Acute Coronary Syndrome 

Diagnostics FDA Cardiology

 News Release - January 3, 2006

FDA Clears NT-proBNP Test for New Risk Stratification Use

Roche Elecsys(R) proBNP test provides risk assessment of cardiac events for people with stable coronary artery disease

INDIANAPOLIS, Jan. 3 (HSMN NewsFeed) -- Nearly 13 million Americans have stable coronary artery disease(1), and people with this condition are at a higher risk of developing adverse cardiac events than the general population. The Roche Elecsys proBNP assay is the first and only natriuretic peptide test to receive FDA clearance for the risk assessment of cardiac events in people with this disease state. The test is available for use on the Roche Elecsys systems and MODULAR ANALYTICS E170 immunoassay analyzers.

"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," said Mike Samoszuk, MD, Chief Medical Officer, Roche Diagnostics Corporation. "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. Laboratory tests like this are changing the way physicians approach patient care. Roche Diagnostics is proud to be the leader in the cardiac marker market with its NT-proBNP test and other important assays."

Since its market introduction in 2002, Roche Diagnostics' successful Elecsys proBNP cardiac assay has seen a steady expansion of its clinical utility in cardiovascular disease and in disease that eventually involves the heart. proBNP is FDA-cleared as an aid in the diagnosis of individuals suspected of congestive heart failure, and as a marker of risk for patients with Acute Coronary Syndrome (ACS) and congestive heart failure.

Roche Diagnostics has recently moved to the number one position worldwide in the cardiac marker market, and proBNP is the only natriuretic peptide test that is approved in the U.S. for cardiac risk stratification in people with coronary artery disease.

About Cardiac Disease

Today, cardiac diseases represent a major health issue frequently found in all populations; its associated economic burden is expected to continue to rise in the coming years because of the worldwide aging population and the increased survival rate from acute coronary events, such as heart attacks.

Coronary artery disease occurs when the coronary arteries, those that supply blood to the heart muscle, become hardened and narrowed. The arteries harden and become narrow due to the buildup of plaque on the inner walls or lining of the arteries, known as atherosclerosis. The plaque buildup reduces blood flow and oxygen to the heart and can lead to angina, which is chest pain or discomfort that occurs when the heart is not getting enough blood, or even a heart attack.(2)

According to the National Heart, Lung, and Blood Institute, coronary artery disease is the most common type of heart disease. It is the leading cause of death in the U.S. in both men and women.

About Roche and the Roche Diagnostics Division

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai.

Roche's Diagnostics Division offers a uniquely broad product portfolio and supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide. For further information, please visit our websites and . Roche Diagnostics' North American headquarters is located in Indianapolis, Ind. ( ).

(1) Clinical Performance Measures, Chronic Stable Coronary Artery Disease, American Medical Association, 2003

(2) Diseases and Conditions Index, National Heart, Lung, and Blood Institute, August 2003.

ELECSYS and MODULAR are a trademarks of Roche.

Source: Roche Diagnostics

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