Roche introduces new cobas p 630 Instrument and AMPLILINK 3.3 Series Software with CE Mark

New pre-analytical solution that integrates automated primary tube handling.

Roche Molecular Diagnostics (SIX: RO, ROG; OTCQX: RHHBY) announced today the availability of the cobas p 630 Instrument with CE Mark and the AMPLILINK 3.3 Series Software. The cobas p630 Instrument and the AMPLILINK 3.3 Series Software is intended for the E.U. and countries outside the United States that accept products with the CE Mark. With this introduction, Roche has the only pre-analytical instrument that unites primary tube handling with fully automated sample preparation, amplification and detection for molecular diagnostics. The AMPLILINK 3.3 Series Software is the latest version of the widely adopted software that integrates the cobas p 630 Instrument with the market leading COBAS® AmpliPrep Instruments and COBAS® TaqMan® Analyzers.

Jeff Heimburger, International Business Leader of Virology at Roche Molecular Diagnostics said, “The complete system provides our customers in the E.U. and countries outside the U.S. that accept CE Marked products with a flexible and integrated solution with automated pre-analytics and real-time PCR diagnostic testing for a broad menu of important molecular tests (HIV, HCV, and HBV).”

The cobas p 630 Instrument provides a state-of-the art, automated pre-analytical solution for primary tube handling and features full sample traceability and process surveillance. These features effectively eliminate manual steps, pipetting errors, and the associated risks of repetitive stress injuries.

“We are excited by the addition of the cobas p 630 Instrument to our portfolio. Combined with AMPLILINK 3.3 Series Software, the cobas p 630 Instrument specifically addresses the throughput needs of a key customer segment while at the same time reduces hands-on time, a critical measure for lab efficiency,” said Neil Gunn, Head of Global Business at Roche Molecular Diagnostics.

About the cobas p 630 Instrument and AMPLILINK 3.3 Series Software
The Roche cobas p 630 Instrument is an automated pre-analytical instrument for primary tube handling. The automation features include: de-capping and capping of the sample tube; pipetting Roche controls from control tubes to sample tubes; pipetting samples from primary tubes to multiple sample tubes. The cobas p 630 Instrument is compatible with a variety of standard primary tubes. Bar-code tracking from primary tube to result ensures full sample traceability. Maximum sample throughput is 154 samples per hour.

The 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. MPLILINK 3.3 Series Software manages the operation of the connected COBAS® Instruments and Analyzers. One AMPLILINK data station is capable of supporting up to 3 COBAS® AmpliPrep Instruments and 3 Analyzers (combination of COBAS® AMPLICOR®, COBAS® TaqMan® and COBAS® TaqMan® 48 Analyzers), together with the cobas p 630 Instrument for pre-analytics.

About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients.

In 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.

ROCHE, COBAS, COBAS P, AMPLIPREP, AMPLICOR, TAQMAN and AMPLILINK are trademarks of Roche.
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For further information please contact:

Jessica Brillant, Roche Molecular Diagnostics, Pleasanton, CA
Office: 925-730-8503
Mobile: 925-980-0260
Email: Jessica.brillant@roche.com

Rick Roose, Roche Molecular Diagnostics, Pleasanton, CA
Office: 925-730-8415
Mobile: 925-819-0609
Email: Rick.roose@roche.com