FDA News

FDA Approves Siemen's Versant 440 Molecular System

(Feb 26, 2008)-- "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 on FDA's approval of Versant 440 Molecular System.

"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." added Okrongly.

Siemens Healthcare's Versant 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.

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.

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