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Roche Receives FDA Approval for cobas p 630 Pre-analytical Solution for Automated Molecular Testing Platform
Date:3/30/2012

PLEASANTON, Calif., March 30, 2012 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the FDA approval of a new pre-analytical instrument that provides an integrated primary tube handling solution for its widely adopted automated molecular testing platform. The cobas p 630 Instrument, being introduced with new AMPLILINK 3.3 series software, unites primary tube handling with fully automated sample preparation, amplification and detection for molecular diagnostics on COBAS® AmpliPrep instruments and COBAS® TaqMan® analyzers.

"The complete system provides molecular laboratories with a flexible and integrated solution for automated pre-analytics and real-time PCR diagnostic testing," said Paul Brown, Ph.D., Head of Roche Molecular Diagnostics. "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."

The cobas p 630 Instrument is designed to protect the integrity of the primary patient tube and combines automated primary tube handling with full sample traceability, process surveillance and bi-directional connectivity. Together, these features help labs improve efficiency by effectively eliminating manual steps.

The cobas p 630 Instrument has a number of additional automation features that ensure full sample traceability while reducing hands-on labor time. The cobas p 630 Instrument received CE mark in October 2009 and is used throughout Europe, Africa, Asia and South America.

About AMPLILINK 3.3 series software
AMPLILINK Software, a Windows® operating system-based application, is designed to deliver maximum flexibility, efficiency and integrity to the laboratory's workflow – from sample input through results output. AMPLILINK 3.3 series software is an intuitive graphical user interface that manages the operation of the connected CO
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