Skip to Content

Investor Update

Basel, 21 July 2009

Roche Diagnostics showcases new technology at Clinical Lab Expo

Lab and point-of-care solutions designed to help improve productivity, enhance patient care

Roche Diagnostics is featuring a diverse portfolio of solutions designed to help healthcare facilities and reference labs do more with less and enhance patient care in booth #1331 at the AACC/CSCC 2009 Clinical Lab Expo here, July 21-23.

The Roche booth includes new diagnostics technology and related productivity solutions, such as integrated clinical chemistry and immunoassay analyzer platforms, automation components, information technology solutions, handheld and mobile point-of-care systems, and chemistry, immunoassay and molecular diagnostics tests.

New products that will be featured in the booth include:

cobas® 8000 analyzer series*

Being designed to bring next-generation consolidation to the high-volume testing lab, the cobas 8000 analyzer series is intended for labs processing greater than two million clinical chemistry and immunoassay tests per year. The series consists of four analytical chemistry/immunoassay modules (cobas c 701*, cobas c 502*, cobas ISE module*, and cobas e 602*) that can be configured into 19 unique combinations to fit the needs of a wide variety of testing environments. In addition to having several features new to the cobas analyzer series, the system is being designed to produce an integrated CC/IA menu throughput up to 4,740 tests/hour or serve as a single high-volume automation chemistry platform with a maximum throughput of 8,400 tests/hour while using only a single entry point. Expected availability is April 2010.

* In development. This product is not cleared or available for use in the U.S.

LightCycler® MRSA Advanced Test*

The LightCycler MRSA Advanced Test is a qualitative in-vitro diagnostic test for the direct detection of nasal colonization with methicillin-resistant Staphylococcus aureus (MRSA). The test is designed to aid in the prevention and control of MRSA infections in healthcare settings. It will be performed on Roche’s LightCycler 2.0 Instrument with nasal swab specimens from patients suspected of colonization, using Roche’s patented real-time polymerase chain reaction (PCR) technology. Designed to offer a convenient, ready-to-use format and flexible batch sizes, the LightCycler MRSA Advanced Test is intended to help ensure the safety and productivity of laboratory staff and provide flexible throughput and accurate and reliable results. Expected availability is August 2009.

* This product is not cleared or available for use in the U.S. A 510(k) submission is pending.

ACCU-CHEK® Inform II System*

Currently pending FDA 510(k) clearance, the ACCU-CHEK Inform II blood glucose monitoring system is designed to introduce several technological innovations to help improve patient safety and care, improve access to data, and enhance system durability at the point of care. Design goals include both wired and wireless connectivity, with no need to dock the meter to transmit patient results wirelessly; test strip underdose detection; small sample size and fast test results; centralized management of test strip lot data; advanced bar code scanning for accurate patient ID confirmation; a new durable meter design for optimal performance and easy cleaning; and connectivity to the RALS®-Plus data management system to allow access to patient data from virtually anywhere in the hospital. Expected availability is sometime in 2009.

* This product is not cleared or available for use in the U.S. A 510(k) submission is pending.

cobas p 701 Post Analytical Unit*

Developed to help streamline a lab’s workflow and manage the entire life cycle of a sample tube, the cobas p 701 post analytical unit is being designed to provide automated storage and retrieval for up to 30,000 sample tubes in a compact footprint (17 linear ft). It is being designed to connect directly to Roche automation, store up to 400 samples per hour in a convenient refrigerated environment, and automatically dispose of samples after a designated period of time. The unit is also being designed to receive sample retrieval requests for add-on tests immediately via integration with the laboratory information system (LIS). Expected availability for the standalone system is October 2009.

* In development. This product is not cleared or available for use in the U.S.

cobas c 311 Clinical Chemistry Analyzer

The cobas c 311 Clinical Chemistry Analyzer was designed to help smaller laboratories expand operations or more easily adjust to busy workloads. Offering comprehensive features in a compact footprint of less than 20 square feet, the cobas c 311 analyzer is ideally suited for labs running 80 to 200 samples per day or 50,000 to 500,000 tests per year. It offers a full menu including general chemistries, TDMs, DATs and serum proteins; ready-to-use reagent packs; throughput of up to 300 tests per hour; STAT interrupt capabilities; and onboard capacity of 42 channels and 3 ISEs. The analyzer uses the same operator interface and reagents as larger Roche systems, and its size and breadth of menu make it flexible enough to use in routine, satellite, STAT and dedicated labs. The cobas c 311 analyzer and the cobas e 411 immunoassay analyzer make up the cobas® 4000 series, which can help labs optimize their workflow by consolidating multiple platforms. Introduced in May 2009.

Roche Cardiac 200

The latest addition to an expanding portfolio of Roche Diagnostics cardiac solutions, the Roche Cardiac 200 is a lateral flow immunoassay testing system designed for rapid cardiac diagnostic needs at the point of care. The system provides quantitative results with a turnaround time of only 10 to19 minutes and uses a unique internal corrected fluorescence measurement technology to deliver accuracy and reliability that are consistent with the performance expectations of laboratory systems as defined by the NACB.1 Offering a full cardiac marker menu that includes NT-proBNP, Troponin I (TnI), CKMB and Myoglobin, it processes up to 36 tests per hour and offers flexible modular configurations to enable labs to address specific workflow needs. Introduced in April 2009.

Task Targeted Automation (TTA)

The next generation in total lab automation products, the RSA Pro and RSD Pro systems from Roche Diagnostics provide customized sample handling solutions for improved workflow. The standalone systems offer high-speed throughput and enable high-volume labs to easily manage specimen processing during the pre-analytical (sorting and /or aliquoting) and post-analytical (archiving) phases. Fully scalable and extendable, Roche task targeted automation can improve efficiency while helping to reduce operator exposure to potentially hazardous biological materials and eliminate repetitive stress injuries. Introduced in May 2009.

Note to editors: The RSA Pro and RSD Pro TTA systems are manufactured by PVT, a strategic business partner. Demonstrations will be available at PVT’s booth at the Clinical Lab Expo.

cobas® TaqScreen MPX Test

The cobas TaqScreen MPX Test, for use with the cobas s 201 system, uses real-time PCR technology to screen samples from living donors, including donors of whole blood, blood components, and organs. It is a qualitative in-vitro test for the direct detection of five targets in a human plasma sample: Human Immunodeficiency Virus Type 1 (HIV-1) Group M RNA, Human Immunodeficiency Virus Type 1 Group O RNA, Human Immunodeficiency Virus Type 2 (HIV-2) RNA, hepatitis C virus (HCV) RNA and hepatitis B virus (HBV) DNA. Packaged in ready-to use reagent cassettes, the test was developed specifically for use on Roche’s cobas s 201 system, a complete nucleic acid testing (NAT) solution for blood screening labs. Introduced in January 2009.

CoaguChek XS Plus System Handheld Base Unit

The new Handheld Base Unit for the CoaguChek® XS Plus System provides connectivity between the anticoagulation meter and the RALS®-Plus data management system and enables hospital networks to easily capture, access and manage essential patient, operator and quality data for point-of-care PT/INR (clotting time) testing. The connectivity capability with Medical Automation Systems’ RALS-Plus allows for network-wide data management and bi-directional data transfer with anticoagulation meters, which can help point of care (POC) coordinators and others ensure the accuracy of patient records and help improve the safety of patients on blood-thinning medications, such as Coumadin® (warfarin). The reporting and device management capabilities of RALS-Plus can also help hospital staff streamline the regulatory compliance process, capture reimbursable costs, and improve their organizational efficiency. Introduced in November 2008.

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.

All trademarks used or mentioned in this release are protected by law. RALS is a trademark of Medical Automation Systems, Inc. COUMADIN is a trademark of Bristol-Myers Squibb Pharma Company.

1) Christenson R. The National Academy of Clinical Biochemistry. Laboratory Medicine Practice Guidelines: Biomarkers of acute coronary syndrome and heart failure. 2007.