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FDA Approves Roche's Pre-analytical Tool for Cobas System

NEW YORK (GenomeWeb News) – Roche today said that the US Food and Drug Administration has approved its pre-analytical instrument, which provides "an integrated primary tube handling solution" for its Cobas automated molecular testing platform.

The cobas p 630 instrument integrates tube handling with fully automated sample preparation amplification and detection for molecular diagnostics on Roche's Cobas AmpliPrep instruments and Cobas TaqMan Analyzers, the company said. Roche is introducing the instrument with new AmpliLink 3.3 series software.

Cobas p 630 protects the integrity of the primary patient tube and "combines automated primary tube handling with full sample traceability, process surveillance, and bi-directional connectivity," Roche said. The instrument received CE marking and was launched in Europe in October 2009. Additionally, it is used in Asia, Africa, and South America.

"The complete system provides molecular laboratories with a flexible and integrated solution for automated pre-analytics and real-time PCR diagnostic testing," Paul Brown, head of Roche Molecular Diagnostics, said in a statement. "Combined with the latest version of our software, the cobas p 630 Instrument helps labs enhance their throughput for a broad menu of important molecular virology tests, including HIV, hepatitis B and hepatitis C."

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