Healthcare Industry News:  antiviral 

Diagnostics FDA

 News Release - February 18, 2008

Siemens Receives FDA Approval for the VERSANT 440 Molecular System

Siemens Offers Next Generation Molecular Viral Load Testing to the U.S. Market

DEERFIELD, Ill., Feb. 18 (HSMN NewsFeed) -- Siemens Healthcare (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.

"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 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.


Source: Siemens

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