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Proteome Sciences results in big news CJD + Stroke tests
FSE - Wed, 31 Dec 03 :
Meg.... the whole point of my post is to say that the UK are NOT the only country with research programs of a level sophisticated enough to already have a BSE test. I feel people vastly underestimate the competition from North America.
The UK is no longer the centre of the universe....
How about this for most recent that I have seen ... maybe you were in the garden ?
Biosite(R) Receives FDA Clearance For Triage(R) BNP Test for Beckman Coulter Platforms
Biosite First to Offer Choice of Platforms For 'Gold Standard' Heart Failure Test
SAN DIEGO, Dec. 30 /PRNewswire-FirstCall/ -- Biosite Incorporated (Nasdaq: BSTE) announced today that it has received clearance from the United States Food and Drug Administration (FDA) to market the Triage(R) 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 United States through Biosite's direct sales force and Fisher Healthcare. Under the terms of the agreement signed between Biosite and Beckman Coulter, Inc. (NYSE: BEC) 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 chief executive officer. "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(R) and Access 2 immunoassay systems, SYNCHRON LX(R)i 725 combination chemistry and immunoassay workstation, and the new high-throughput UniCel(TM) 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."
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