ABBOTT PARK, Ill., Feb. 3 /PRNewswire-FirstCall/ -- Abbott Laboratories today announced that its manufacturing partner, Axis-Shield, has received clearance from the U.S. Food and Drug Administration for a B-type Natriuretic Peptide (BNP) test for use on Abbott's AxSYM(R) automated immunoassay instrument system. BNP is a cardiac marker used in the diagnosis and assessment of severity of heart failure.
Abbott expects the AxSYM BNP test to be available in the United States in February. In November, Abbott introduced the test in major markets outside the United States and Japan.
"We're delighted that an automated BNP test will now be available to hospitals and clinical laboratories in the United States who use Abbott's AxSYM instrument system," said Joseph M. Nemmers, senior vice president, Diagnostics Operations, Abbott Laboratories. "With AxSYM BNP, physicians will have another important cardiac test to improve patient care."
BNP is a cardiac hormone secreted from the cardiac myocytes (muscle cells) as a response to increased blood pressure and volume overload. Levels of BNP have been shown to be elevated in patients with early signs of cardiac dysfunction and overt heart failure.
"I find that BNP measurement greatly facilitates the clinical care of heart failure patients because it provides a quantitative and validated metric of disease severity," said Michael S. Parmacek, M.D., chief of cardiovascular medicine, University of Pennsylvania.
"With the addition of BNP, we now have a full menu of diagnostic markers used to manage patients with cardiac disease on our AxSYM system, including tests for troponin-I, CK-MB and myoglobin. These markers along with homocysteine, which has been associated with increased risk of cardiovascular disease, can help physicians make accurate clinical decisions," said Douglas C. Bryant, vice president, Global Commercial Operations, Diagnostics, Abbott Laboratories.
Axis-Shield is a 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. Axis-Shield has partnered with Abbott to introduce several new tests on both the IMx(R) and AxSYM(R) systems, Abbott's market-leading automated immunoassay analyzers. News releases and company information are available at http://www.axis-shield.com/ .
Abbott Laboratories is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals, nutritionals, and medical products, including devices and diagnostics. The company employs more than 70,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com/ .