FDA approves Roche's cobas p 630 pre-analytical instrument

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.