FDA Clears bioMérieux's VIDAS® NT-proBNP, a High Medical Value Test for Diagnosis of Heart Failure

VIDAS® NT-proBNP (N-terminal pro-B-type natriuretic peptide) is a quantitative marker of heart stress with the potential to detect all stages of heart failure, even the early stages, which can be difficult to detect. The test provides objective diagnostic information that helps clinicians distinguish heart failure from other disease states with similar clinical symptoms, for instance lung diseases or pulmonary embolism.

“With this new FDA approval, bioMérieux is building a substantial panel of high medical value assays for the VIDAS® system in the U.S. VIDAS NT-proBNP is a proven marker for heart failure and will provide clinicians with a powerful tool for the management of life-threatening cardiac pathologies,” declared Stéphane Bancel, Chief Executive Officer of bioMérieux.

NT-proBNP can also be used to assess the prognosis of patients with established heart failure or acute coronary syndrome. Its measurement is cost-effective and leads to important healthcare cost-savings as shown by analysis from a study at Harvard Medical School’s Brigham and Women's Hospital in Boston and a pivotal randomized multi-center study in Canada . The latter study reported a reduction in direct medical costs of 15% (USD 949 per patient) when NT-proBNP testing was part of routine assessment of emergency department patients with dyspnea (shortness of breath).

The unique VIDAS design makes this assay available 24 hours a day for emergency departments. The VIDAS® Emergency Panel available in the U.S. includes markers of cardiac necrosis (VIDAS® Troponin I, CK-MB), venous thromboembolism (VIDAS® D-Dimer Exclusion™) and bacterial infections (VIDAS® B.R.A.H.M.S PCT). Over 24,000 VIDAS systems are installed worldwide.

About Heart Failure

Heart failure is a major healthcare issue, whose frequency is expected to continue to rise in the coming years due to the worldwide aging population and increased survival rate from acute coronary events.

It is the leading cause of hospitalization in people over 65 years of age, affecting up to 17 million people worldwide. In the U.S., 5 million people suffer from heart failure, and 550,000 new cases are diagnosed each year .

About NT-proBNP

NT-proBNP belongs to the family of B-type natriuretic peptides like BNP. In the case of heart failure, when the heart is unable to pump blood efficiently, the increased stress on the heart cells results in increased secretion of NT-proBNP. As a result, elevated levels of the NT-proBNP molecule are detected in the blood and can be directly correlated to the severity of heart failure.

About bioMérieux

Advancing Diagnostics to Improve Public Health

A world leader in the field of in vitro diagnostics for 45 years, bioMérieux is present in more than 150 countries through 38 subsidiaries and a large network of distributors. In 2007, revenues reached €1.063 billion with 84% of sales outside of France.

bioMérieux provides diagnostic solutions (reagents, instruments, software), which determine the source of disease and contamination to improve patient health and ensure consumer safety. Our products are used for diagnosing infectious diseases and providing high medical value results for cardiovascular emergencies and cancer screening and monitoring. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products. bioMérieux is listed on Eurolist by Euronext. For more information, visit http://www.biomerieux.com/.

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¹ Siebert U, Januzzi JL Jr, Beinfeld MT, Cameron R, Gazelle GS. Cost-effectiveness of using N-terminal pro-brain natriuretic peptide to guide the diagnostic assessment and management of dyspneic patients in the emergency department. Am J Cardiol. 2006;98:800-5.

² Moe G.W, Howlett J, Januzzi JL, et al. N-terminal Pro-B-type natriuretic peptide testing improves the management of patients with suspected acute heart failure. Primary results of the Canadian prospective randomized multicenter IMPROVE-CHF study. Circulation 2007;115: 3103-3110

³ Rosamond W, et al. Heart disease and stroke statistics –2007 update. A report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation 2007; 115:e69-e171.