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VERSANT™ 440 FDA Approved for HCV

Siemens Healthcare has announced that its 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.

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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Source : Siemens Healthcare Diagnostics View Company Information

Posted on February 19, 2008