Siemens Healthcare's Versant 440 molecular system
This article was originally published in Clinica
Executive Summary
Siemens Healthcare's Versant 440 molecular system has been awarded a supplementary PMA by the US FDA and may now be used in conjunction with the Versant HCV RNA 3.0 assay. The HCV RNA assay is used to manage the antiviral therapy given to hepatitis-C virus (HCV)-infected patients - interferon alfa-2b plus ribavirin. It measures HCV RNA levels at baseline and during treatment, and predicts the patients' virological response. The Versant 440 is a branched DNA system that bypasses nucleic acid extraction and reduces the risk of cross-contamination. It can integrate bar code data entry, automate reagent processing, perform signal amplification detection, and incorporates a Laboratory Information System which allows operators to download results. When run on the Versant 440, the HCV RNA 3.0 assay demonstrates "excellent precision across the entire reporting range and equivalent detection of all HCV RNA genotypes", Siemens claims. The Deerfield, Illinois firm CE marked the Versant 440 in September 2006, and has launched it throughout Europe, Africa, and parts of Asia and the Americas.