Dade Behring Holdings, Inc. (NASDAQ:DADE) today announced that its NT-proBNP (N-terminal pro brain natriuretic peptide) test has received FDA clearance for two additional claims - assessment of heart failure severity in patients diagnosed with congestive heart failure, and risk stratification of patients with acute coronary syndrome and heart failure. Earlier, clearance was received for the use of NT-proBNP in the diagnosis of individuals suspected of having congestive heart failure. The fully-automated test is available for use on the Dimension(R) instruments with Heterogeneous Immunoassay Module.
"The availability of the NT-proBNP test is the kind of incremental innovation that demonstrates our commitment to provide our customers with the assays they need to provide accurate diagnosis of many life-threatening cardiac conditions," said Jim Reid-Anderson, Chairman, President and CEO of Dade Behring. "Having the ability to assess the severity and risk stratification of coronary heart disease, the number one cause of death in developed countries, significantly strengthens our leadership position in the cardiac marketplace."
In individuals suspected of having congestive heart failure (CHF), measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity. The test is further indicated for the risk stratification of patients with acute coronary syndrome and heart failure.
Studies indicate that NT-proBNP can be used in diagnostic and prognostic applications.(1) The concentration of NT-proBNP in plasma indicates the prognosis for the left ventricular dysfunction. It is also useful in assigning symptoms to cardiac or non-cardiac causes.
About NT-proBNP
B-type natriuretic peptide (BNP) is secreted by the left ventricle when the heart is unable to pump blood efficiently. BNP dilates blood vessels and promotes sodium and water loss, reducing fluid load on the heart and improving cardiac performance. N-terminal proBNP (NT-proBNP) is released at the same time as BNP. Elevated plasma NT-proBNP indicates the presence of heart failure and provides information about its severity: the higher the blood levels of NT-proBNP, the more serious the condition. NT-proBNP levels have been demonstrated to be a diagnostic aid in identifying left ventricular dysfunction, allowing physicians to differentiate between heart failure and lung disorders with similar symptoms(2,3).
About Congestive Heart Failure
Congestive heart failure, or heart failure, is a condition in which the heart cannot pump sufficient blood to other organs in the body. Reasons for heart failure include coronary heart disease (CHD) and myocardial infarction. CHD, a narrowing of arteries that supply blood to the heart, is the number one cause of death worldwide and the prevalence of occurrence is expected to continue to rise due to an aging population and increase in acute coronary syndrome survival. Heart failure is often difficult to diagnose, since its symptoms are nonspecific and are sometimes confused with those of other conditions such as chronic obstructive pulmonary disease. Echocardiography, the gold standard for diagnosis of left ventricular dysfunction, is expensive and not always easily accessible.
About Acute Coronary Syndrome
Acute Coronary Syndrome (ACS) is an umbrella term used to cover any group of clinical symptoms compatible with acute myocardial ischemia. Acute myocardial ischemia, an insufficient blood supply to the heart muscle that results from coronary heart disease (also called coronary artery disease), is often accompanied by chest pain. Severe interruption of the blood supply to myocardial tissue may result in necrosis of cardiac muscle or myocardial infarction. The criteria for the diagnosis of a myocardial infarction includes the three following events: chest pain, serum markers, and ECG changes. This life-threatening disorder is a major cause of emergency medical care and hospitalization in the United States.
With 2003 revenues of more than $1.4 billion, Dade Behring is the world's largest company dedicated solely to clinical diagnostics. It offers a wide range of products, systems and services designed to meet the day-to-day needs of labs, delivering innovative solutions to customers and enhancing the quality of life for patients. Additional company information is available on the Internet at www.dadebehring.com.
1. Struthers AD. How to use natriuretic peptide levels for diagnosis and prognosis. The European Society of Cardiology. Eur Heart J 1999:20:1374-1375.
2. Hammerer-Lercher A, et.al. Head-to-head comparison of N-terminal pro-brain natriuretic peptide, brain natriuretic peptide and N-terminal pro-atrial natriuretic peptide in diagnosing left ventricular dysfunction. Clinica Chimica Acta 2001;310: 193-197.
3. Lainchbury LG, et.al., Brain Natriuretic peptide and N-terminal brain natriuretic peptide in the diagnosis of heart failure in patients with acute shortness of breath. JACC 2003;42:728-735.