Abbott Laboratories announced that its manufacturing partner, Axis-Shield, has submitted a Premarket Notification 510(k) Application with the US Food and Drug Administration (FDA) seeking clearance of a B-type Natriuretic Peptide (BNP) test for use on Abbott's widely used Axsym automated immunoassay instrument system. BNP is a cardiac marker used in the diagnosis of heart failure.
In November, Abbott introduced the test in major markets throughout the world, except the United States and Japan. Following appropriate clearance by the FDA, Abbott will introduce the Axsym BNP test in the US.
"With the increasing incidence of cardiac disease in an aging population, BNP is an important diagnostic marker to help physicians distinguish heart failure from other causes of shortness of breath, improving the accuracy of patient management decisions," said Rick Axelrod, MD, senior director, Medical and Clinical Affairs, Abbott Laboratories.
BNP is a cardiac hormone secreted from the membrane of the cardiac ventricles as a response to increased blood pressure and volume overload. Clinical studies have indicated that BNP can be used for patient diagnosis and prognosis. Levels of BNP have been shown to be elevated in patients with cardiac dysfunction. Plasma BNP levels provide clinically useful information concerning the diagnosis and management of left ventricular dysfunction and heart failure, which complements other diagnostic testing procedures, such as electrocardiograms, chest X-rays, and echocardiograms. BNP levels can be used to assess the severity of heart failure, as demonstrated by the correlation with New York Heart Association classifications.
The performance of the Axsym BNP test was highlighted recently in a series of poster presentations at the annual meeting of the American Association of Clinical Chemistry in Philadelphia, Pennsylvania, and the European Congress of Clinical Chemistry and Laboratory Medicine in Barcelona, Spain.
Heart failure is a syndrome caused by a variety of conditions such as coronary artery disease, hypertension, valve disease, myocarditis and others. Common symptoms of heart failure include shortness of breath, coughing under exertion, swelling of arms and legs, and dizziness. Heart failure is better defined as the progressive inability of the heart ventricles to pump blood out to the lungs and/or the extremities. According to the American Heart Association, there are approximately five million cases of heart failure in the United States alone, with 550,000 new cases diagnosed each year.
Axis-Shield is global manufacturer of in vitro diagnostic kits with a focus on new markers in cardiovascular, rheumatoid, infectious and alcohol-related diseases, diabetes, dementia and near patient testing to facilitate improved patient management.