Siemens Receives FDA Approval for the VERSANT 440 Molecular System
19 February 2008 - 1:00AM
PR Newswire (US)
Siemens Offers Next Generation Molecular Viral Load Testing to the
U.S. Market DEERFIELD, Ill., Feb. 18 /PRNewswire/ -- Siemens
Healthcare (http://www.siemens.com/diagnostics) announced today
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. (Photo:
http://www.newscom.com/cgi-bin/prnh/20080218/NYM009 ) (Logo:
http://www.newscom.com/cgi-bin/prnh/20070904/SIEMENSLOGO ) "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.
http://www.newscom.com/cgi-bin/prnh/20080218/NYM009
http://www.newscom.com/cgi-bin/prnh/20070904/SIEMENSLOGO
http://photoarchive.ap.org/ DATASOURCE: Siemens Healthcare CONTACT:
Amanda Naiman of Siemens Healthcare, +1-610-448-4531, Web site:
http://www.usa.siemens.com/medical
http://www.siemens.com/diagnostics
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