Abbott Laboratories announced that its manufacturing partner, Axis-Shield, has received clearance from the US Food and Drug Administration for a B-type Natriuretic Peptide (BNP) test for use on Abbott's Axsym 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 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 Parmacek, 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 Bryant, vice president, Global Commercial Operations, Diagnostics, Abbott Laboratories.