The FDA has approved a new pre-analytical instrument that provides an integrated primary tube handling solution for Roche’s 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 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.

Source: Roche