Abbott and Axis-Shield Announce US 510(K) Submission and Non-US Launch Of AxSYM(R) BNP Test for Heart Failure
08 Dicembre 2003 - 1:01PM
PR Newswire (US)
Abbott and Axis-Shield Announce US 510(K) Submission and Non-US
Launch Of AxSYM(R) BNP Test for Heart Failure - Elevated Levels of
B-type Natriuretic Peptide (BNP) are Associated with Cardiac
Dysfunction or the Severity of Heart Failure - ABBOTT PARK, Ill.,
Dec. 8 /PRNewswire-FirstCall/ -- Abbott Laboratories today
announced that its manufacturing partner, Axis-Shield, has
submitted a Premarket Notification 510(k) Application with the U.S.
Food and Drug Administration (FDA) seeking clearance of a B-type
Natriuretic Peptide (BNP) test for use on Abbott's widely used
AxSYM(R) 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 United States.
"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, M.D., 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, Pa., and the European Congress
of Clinical Chemistry and Laboratory Medicine in Barcelona, Spain.
About Heart Failure 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. About Axis-Shield 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. 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/ . About Abbott 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. In 2002, the
company's sales were $17.7 billion. Abbott's news releases and
other information are available on the company's Web site at
http://www.abbott.com/ . DATASOURCE: Abbott Laboratories CONTACT:
Media: Don Braakman, +1-847-937-1237; Financial Community: Christy
Wistar, +1-847-938-4475, both of Abbott Laboratories Web site:
http://www.abbott.com/ http://www.axis-shield.com/ Company News
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