Navigation Links
Roche Receives FDA Clearance for U.S. Launch of cobas 8000 Modular Analyzer Series for High-Volume Laboratory Testing

INDIANAPOLIS, Sept. 13 /PRNewswire-FirstCall/ -- Roche Diagnostics (SIX: RO, ROG; OTCQX: RHHBY) announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the cobas® 8000 modular analyzer series, a Serum Work Area solution designed for diagnostic laboratories with a workload of 3-15 million clinical chemistry / immunochemistry tests per year.

(Photo: )

(Photo: )

The cobas 8000 series is the newest member of the Roche cobas modular platform family, which combines clinical chemistry and immunochemistry testing. With a peak throughput of up to 9,800 tests per hour and up to 280 reagents onboard, it offers a variety of features to help high-volume labs deliver reliable test results with greater efficiency and throughput. The system also provides extensive modular flexibility so labs can configure tailored solutions to meet their individual needs.

With the introduction of the cobas 8000 modular analyzer series, Roche now offers a comprehensive portfolio of standardized integrated systems to meet the needs of all types and sizes of clinical laboratories: the stand-alone cobas 4000 analyzer series for low-volume labs; the cobas 6000 analyzer series for mid-volume labs; and the cobas 8000 modular analyzer series for high-volume labs.

"The cobas 8000 modular analyzer series delivers a new dimension in productivity, process innovation and consolidation for high-volume laboratories," said Jack Phillips, president and CEO of Roche Diagnostics Corporation. "There are many innovative design elements that help reduce sample turnaround time, and the modular design gives labs the freedom to reconfigure their system on-site as they grow or their needs change."

The cobas 8000 modular analyzer series features intelligent sample routing with fast transportation and return lines, independent processing lines within each module, and a modular sample buffer in each module for true random-access sampling. The series also uses the same operator interface and the standardized reagent cassette concept used on other cobas analyzer platforms. Tests run on the new platform give physicians important clinical information in a wide range of medical areas, such as cardiac and infectious diseases, bone disorders and cancer.

The first configuration of the system, which will be available September 20, includes two clinical chemistry analytical modules: the high-volume cobas c 701 module (up to 2000 tests/hour) and the mid-volume cobas c 502 module (up to 600 tests/hour). The system automatically manages samples to provide optimal throughput by allocating the most frequently requested assays to the high-volume module and less frequently requested assays to the mid-volume module.

Roche anticipates that the system's immunochemistry module, the cobas e 602 analyzer, will be available in October 2010. (The cobas e 602 module is currently in development/for research use only. The product is not available in the U.S.). With the addition of this module, laboratories will be able to combine chemistry and immunochemistry modules to create 24 unique system configurations to match their specific testing needs.

About RocheHeadquartered 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 personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2009, Roche had over 80,000 employees worldwide and invested almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 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: or

All trademarks used or mentioned in this release are protected by law.

For further information, please contact: Betsy Cox Director, Corporate Communications

Roche Diagnostics Corporation

Indianapolis, IN(317)

SOURCE Roche Diagnostics
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Wyeths Torisel and Roche/Genentechs Avastin Will Challenge Pfizers Sutent to Become the Clinical Gold Standard for Treatment of Metastatic Renal Cell Carcinoma
2. Researchers Identify Virus Possibly Responsible for Declining Honeybee Population Using 454 Sequencing Technology from Roche
3. Rochester Medical Anti-Infection Foley Catheter Demonstrates Effectiveness in Randomized Trial
4. MacroChem Acquires Rights to Pexiganan, a Novel Topical Anti-Infective for Treatment of Diabetic Foot Infections, From Genaera
5. Roche Announces Positive Results in Solid Tumors Using Human Monoclonal Antibody Against IGF-1R (R1507)
6. Roche Diagnostics HIV Viral Load Test Used in Clinical Trials for Isentress, a New Class of HIV Drug
7. Roches Investigational Polymerase Inhibitor, Combined with PEGASYS(R) and COPEGUS(TM), Shows Potent Antiviral Activity in Treatment of Chronic Hepatitis C at Four Weeks
8. Two Pivotal Phase III Studies for Roches ACTEMRA(TM) (tocilizumab) Demonstrate Significant Improvement in Rheumatoid Arthritis Symptoms
9. Roche Submits Application for FDA Approval of ACTEMRA(R) for the Treatment of Rheumatoid Arthritis
10. Roche responds to announcement of IDEAL hepatitis C trial results
11. Roche and Pharmasset To Present the R7128 Monotherapy Resistance Profile
Post Your Comments:
(Date:11/26/2015)... 26, 2015 ... "2016 Future Horizons and Growth Strategies ... Market: Supplier Shares, Country Segment Forecasts, Competitive ... offering. --> ) has ... Future Horizons and Growth Strategies in the ...
(Date:11/26/2015)... 2015 ... the  "2016 Future Horizons and Growth ... Monitoring (TDM) Market: Supplier Shares, Country ...  report to their offering.  --> ... addition of the  "2016 Future Horizons ...
(Date:11/26/2015)... DUBLIN , Nov. 26, 2015 ... the addition of the "2016 Future Horizons ... Monitoring (TDM) Market: Supplier Shares, Country Segment Forecasts, ... offering. --> ... comprehensive analysis of the Italian therapeutic drug monitoring ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... 2015 , ... Brillianteen, McGaw YMCA’s student-produced musical show, will ... Anniversary Brillianteen Revue, scheduled for March 4-6, 2016. Auditions for this final production ... been a treasured tradition for numerous families in the Evanston community. Over the ...
(Date:11/25/2015)... , ... November 25, 2015 , ... “While riding the ... inventor, from Bronx, N.Y. “I thought there had to be a convenient and comfortable ... PROTECTOR. , The PROTECTOR enables disabled individuals to safely travel during cold or inclement ...
(Date:11/25/2015)... , ... November 25, 2015 , ... ... provide scholarships for people struggling with eating disorders as a result of the ... second annual event, held at Fox Run Golf Club in Eureka, will help ...
(Date:11/25/2015)... ... 25, 2015 , ... "When I underwent breast reconstruction following ... uncomfortable," said an inventor from Bronx, N.Y. "In order to meet my own ... BRA for added comfort and support. The bra is easier to put on ...
(Date:11/25/2015)... ... ... An unlikely combination of recycled plastic shopping bags in ... to have a more dignified and comfortable night’s sleep. , Residents of Friendship ... bags into sleeping mats for the homeless. The project, according to Jeannette ...
Breaking Medicine News(10 mins):