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FDA Gives Nod for Siemens HCV Monitoring Test

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has approved a hepatitis C viral load assay made by Siemens Healthcare that can help physicians to monitor the disease, the company said today.
 
Siemens said its Versant 440 Molecular System was approved for marketing and for use with the company’s Versant HCV RNA 3.0 assay for management of HCV-infected patients.
 
The Versant 440 viral load measurement system integrates bar code data entry, automated reagent processing, signal amplification detection, and a lab information system interface.
 
The system received its CE Mark in September 2006, and has been launched in Europe, Africa and in parts of Asia and in the Americas, the company said.

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