Press release from PR Newswire
Beckman Coulter Receives FDA Clearance of AccuTnI+3 Troponin I Assay on UniCel DxI Immunoassay Systems
Thursday, September 26, 2013
Beckman Coulter Receives FDA Clearance of AccuTnI+3 Troponin I Assay on UniCel DxI Immunoassay Systems16:00 EDT Thursday, September 26, 2013
Cardiac Disease Management Assay Available on Entire Immunoassay Portfolio
BREA, Calif., Sept. 26, 2013 /PRNewswire/ -- Delivering the precision, clinical sensitivity and clinical specificity necessary to assist physicians with the diagnosis of myocardial infarction (MI), Beckman Coulter, Inc. announces the U.S. Food and Drug Administration (FDA) 510(k) clearance of its new Access AccuTnI+3 troponin I assay for use on the UniCel DxI series of immunoassay systems.
Following the June 2013 clearance of the Access AccuTnI+3 troponin I assay on Beckman Coulter's Access 2 immunoassay analyzer, the new troponin assay is now cleared for use on all of the company's immunoassay systems, as well as the UniCel DxC integrated chemistry and immunoassay series.
"The AccuTnI+3 troponin assay has been clinically proven through a large multi-center study that enrolled more than 1,900 subjects, and it is confirmed that the test provides the clinical performance needed for optimal patient management," said Arnd Kaldowski, president, Beckman Coulter Diagnostics. "Our new troponin I assay is directly aligned with the FDA's October 2010 guidance to manufacturers of troponin assays and confirms our commitment to modernize the performance evaluation of this critical test."
The new troponin I assay continues Beckman Coulter's long history of proven clinical performance in cardiac disease management and ensures that laboratories and clinicians can optimally assist physicians with the diagnosis of MI. AccuTnI+3 delivers clinical sensitivity and specificity aligned with contemporary use of troponin set forth by the FDA and utilizes platform-specific reagents and calibrators.
About Beckman CoulterBeckman Coulter, Inc., based in Orange County, Calif., a subsidiary of Danaher Corporation (NYSE:DHR), develops, manufactures and markets products that simplify, automate and innovate complex biomedical tests. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on six continents. For more than 75 years, our products have been making a difference in peoples' lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care. For more information, visit www.beckmancoulter.com.
Beckman Coulter, the stylized logo, Access, AccuTnI, DxC, DxI and UniCel are registered trademarks of Beckman Coulter, Inc.
About Danaher Danaher Corporation is a science and technology leader that designs, manufactures, and markets innovative products and services to professional, medical, industrial, and commercial customers. Our premier brands are among the most highly recognized in each of the markets we serve. The Danaher Business System provides a foundation to our 63,000 associates around the world, serving customers in more than 125 countries. In 2012, we generated $18.3 billion of revenue. For more information please visit our website: www.danaher.com.
Statements in this release that are not strictly historical, including any statements regarding events or developments that we believe or anticipate will or may occur in the future, are "forward-looking" statements within the meaning of the federal securities laws. There are a number of important factors that could cause actual results, developments and business decisions to differ materially from those suggested or indicated by such forward-looking statements, including those set forth in Danaher's SEC filings, including Danaher's 2012 Annual Report on Form 10-K and Quarterly Report on Form 10-Q for the second quarter of 2013. You should not place undue reliance on any such forward-looking statements. These forward-looking statements speak only as of the date of this release and Danaher does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise.
SOURCE Beckman Coulter, Inc.
For further information: Danaher Corporation, 202-828-0850