Biosite Incorporated announced that it has received clearance from the US Food and Drug Administration (FDA) to market the Triage BNP Test for Beckman Coulter Immunoassay Systems, a diagnostic test that measures B-type natriuretic peptide (BNP). The Triage BNP Test for Beckman Coulter Immunoassay Systems, which was recently launched in Europe, is now available to customers in the US through Biosite's direct sales force and Fisher Healthcare. Under the terms of the agreement signed between Biosite and Beckman Coulter, Inc. in June 2003, Beckman Coulter will manufacture the test for Biosite, and Biosite will exclusively sell and market the product.
"With this addition to Biosite's 'gold standard' BNP product line, a customer can perform BNP testing using either our rapid, portable Triage MeterPlus system or any of Beckman Coulter's automated immunoassay testing platforms, and expect standardized values," said Kim Blickenstaff, Biosite president and CEO. "Offering this range of standardized Triage BNP assays, will make it easier for patients to move between treatment environments that use either platform -- from emergency departments to inpatient acute care facilities to heart failure centers to physician offices."
Designed to provide results standardized to match Biosite's existing rapid, portable Triage BNP Test, the newest BNP test is available for use on Beckman Coulter systems including the Access and Access 2 immunoassay systems, Synchron LX i 725 combination chemistry and immunoassay workstation, and the new high-throughput UniCel DxI 800 Access immunoassay system. Biosite's Triage BNP Test has received FDA clearances for three indications: use in the diagnosis of CHF, use in the assessment of disease severity and use for the risk stratification of patients with acute coronary syndromes, all of which apply regardless of the system on which the test is performed. Through clinical evaluation data, a large publications base, and a proven clinical performance history, BNP has been identified as the marker of choice for those diagnostic applications.
"We are proud to have commercialized this product within six months of announcing our agreement with Beckman Coulter, a remarkable achievement," said Blickenstaff. "Given this experience, we believe that in the future, where appropriate, we can replicate this platform model as we continue to pursue our long-term strategy of bringing novel diagnostic markers and panels to market."
CHF occurs when the heart cannot maintain adequate circulation of blood due to dysfunction of the organ's pumping action. The impairment of arterial circulation deprives vital organs of oxygen and nutrients, and slows removal of the body's wastes. With 550,000 new cases diagnosed annually and more than 250,000 deaths each year in the United States alone, CHF is now characterized in the US as epidemic.
Biosite Incorporated is a research-based company dedicated to the discovery and development of novel protein-based diagnostics that improve a physician's ability to diagnose debilitating and life-threatening diseases.