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Siemens Receives FDA Approval For The VERSANT 440 Molecular System
Siemens Healthcare
(http://www.siemens.com/diagnostics) announced that its VERSANT(TM) 440
Molecular System has been approved for marketing by the U.S. Food and Drug
Administration (FDA) for use with the VERSANT HCV RNA 3.0 assay for
management of HCV-infected patients undergoing antiviral therapy. The
VERSANT 440 Molecular System represents the next generation in automated
viral load testing, providing laboratories with greater throughput and less
hands-on time, maximizing productivity to meet the evolving needs of the
clinical laboratory.
"We are pleased to offer clinical laboratories leading-edge solutions
in molecular diagnostics that support cost-effective and timely screening
and treatment of infectious disease," said Jim Reid-Anderson, Chief
Executive Officer, Siemens Healthcare Diagnostics Division. "The VERSANT
440 Molecular system provides clinical laboratories and physicians an
outstanding tool that enables quantitative monitoring of Hepatitis C and
the delivery of personalized treatment that addresses the unique needs of
every patient."
The VERSANT 440 Molecular System is a branched DNA (bDNA) system
designed for flexible walk-away automation. Its single room technology and
consolidated footprint allow the system the flexibility to fit anywhere in
the clinical laboratory. The VERSANT 440 System streamlines workflow by
integrating bar code data entry, automated reagent processing, signal
amplification detection, and a Laboratory Information System interface for
downloading patient work lists and results.
"At Siemens, we are intently focused on the development of advanced
systems and solutions that will help clinical laboratories enhance their
diagnostic capabilities and the efficiency of their operations," said David
Okrongly, senior vice president, Molecular Diagnostics, Siemens Healthcare
Diagnostics. "We are excited by the VERSANT 440 System's ability to advance
molecular testing capability and productivity for our customers through
optimized automation, system flexibility, and assay performance
excellence."
The VERSANT 440 Molecular System uses bDNA technology that simplifies
testing by eliminating nucleic acid extraction and reducing the risk of
cross-contamination. With a high level of reproducibility, VERSANT HCV 3.0
Assay allows viral load changes to be distinguished accurately, enhancing
hepatitis C viral load management. The HCV RNA 3.0 Assay run on the VERSANT
440 demonstrates excellent precision across the entire reporting range and
equivalent detection of all HCV RNA genotypes. CE Marked in September of
2006, the VERSANT 440 has been successfully launched throughout Europe,
Africa, and parts of Asia and the Americas.
About Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics Division is the leading clinical
diagnostics provider in the world. The company offers health care
professionals the broadest range of diagnostic products and services that
are used for diagnosing medical conditions, monitoring patient therapy and
providing quality health care. Siemens' comprehensive portfolio of
solutions and highly responsive service are designed to improve clinical
outcomes, streamline workflow and enhance the operational efficiency of
clinical laboratories around the world. Visit http://www.siemens.com/diagnostics.
About Siemens Healthcare
Siemens Healthcare is one of the world's largest suppliers to the
healthcare industry. The company is a renowned medical solutions provider
with core competence and innovative strength in diagnostic and therapeutic
technologies as well as in knowledge engineering, including information
technology and system integration. With its laboratory diagnostics
acquisitions, Siemens Healthcare will be the first fully integrated
diagnostics company, bringing together imaging and lab diagnostics,
therapy, and healthcare information technology solutions, supplemented by
consulting and support services. Siemens Healthcare delivers solutions
across the entire continuum of care -- from prevention and early detection,
to diagnosis, therapy and care. The company employs more than 49,000 people
worldwide and operates in 130 countries. In the fiscal year 2007 (Sept.
30), Siemens Healthcare reported sales of euro 9.85 billion (on a pro forma
basis including Dade Behring roughly euro 11 billion), orders of euro 10.27
billion, and group profit of euro 1.32 billion. Further information can be
found by visiting http://www.siemens.com/healthcare.
Siemens Healthcare
http://www.siemens.com/healthcare
Siemens primeºte aprobarea FDA pentru VERSANT 440 molecularã de sistem - Siemens Receives FDA Approval For The VERSANT 440 Molecular System - articole medicale engleza - startsanatate