Beckman Coulter Receives FDA Clearance of AccuTnI+3 Troponin I Assay on UniCel
DxI Immunoassay Systems
Cardiac Disease Management Assay Available on Entire Immunoassay Portfolio
BREA, Calif., Sept. 26, 2013
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
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 Coulter
Beckman 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
Beckman Coulter, the stylized logo, Access, AccuTnI, DxC, DxI and UniCel are
registered trademarks of Beckman Coulter, Inc.
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:
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.
Contact: Danaher Corporation, 202-828-0850
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