The Diagnostics Division of Bayer HealthCare LLC, a member of the Bayer Group announced the availability of Advia Centaur BNP (B-type natriuretic peptide) assay, a fully automated test for use in the diagnosis of heart failure (HF), on its leading automated immunoassay platform -- the Advia Centaur Immunoassay System. Recent research has shown that elevated levels of BNP indicate the presence of heart failure, thus providing physicians with an important diagnostic tool in the early detection and treatment of HF. The assay is currently available only outside the USA.

The BNP molecule is physiologically active and measures the direct biologic response to cardiovascular stress providing a direct reflection of the patient's current status. This allows more timely treatment and patient management. Physicians have been looking for a simple, rapid and accurate blood test that will help in the diagnosis of HF. Now with the automated Advia Centaur BNP assay, physicians have access to a test that will allow them to have valuable information in real time.

"This important diagnostic test will assist cardiologists and emergency room physicians in identifying and managing patients at risk for heart failure," said Hans Hiller, Senior Vice-President Laboratory Testing Segment, Bayer HealthCare LLC, Diagnostics Division. "The new Bayer BNP test represents our ongoing commitment to offer products with high clinical value designed to improve the diagnosis and management of cardiovascular disease."

The BNP assay expands the already comprehensive cardiovascular panel of CK-MB, Myoglobin, Troponin I, and Homocysteine offered on the Advia Centaur system. With Advia Centaur systems operating in laboratories around the world, laboratory professionals have the benefit of using a proven automated platform to report results in as few as 18 minutes. A fully automated test, BNP results are ready in minutes, requiring less hands on labor while reducing human error associated with manual testing.

The BNP market is a new and rapidly expanding area of cardiovascular testing for diagnosis and monitoring of Heart Failure (HF). According to the American Heart Association, 4.8 million Americans are afflicted with HF, with 550,000 cases diagnosed each year. Worldwide, HF is an increasingly significant problem for health care systems and represents a major health care expenditure. Heart failure affects nearly 17 million people worldwide. Prevalence of heart failure is expected to continue to rise, due to the aging population and increase in acute coronary syndrome survival.

HF is more common in older adults, occurring in approximately 2-3% of the adult population and increasing to 5-10% in adults over age 75. Experts agree that early detection of HF is an important factor in reducing mortality and morbidity associated with the condition. However, diagnosis of HF is a complex and often expensive process. The symptoms of HF 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 ventricularr dysfunction, is expensive and not always easily accessible.

The BNP assay is currently available in non-regulated countries outside of the United States. Bayer plans to apply for approval with regulated countries and for the United States Food Drug and Administration (FDA) clearance. Sales will commence upon receipt of approvals.