Navigation Links
Roche Receives FDA Clearance for U.S. Launch of cobas 8000 Modular Analyzer Series for High-Volume Laboratory Testing
Date:9/13/2010

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:  http://www.newscom.com/cgi-bin/prnh/20100913/AQ63309 )

(Photo:  http://photos.prnewswire.com/prnh/20100913/AQ63309 )

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: www.roche.com or www.roche-diagnostics.us.

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) 521-3911betsy.cox@roche.com
'/>"/>

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:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... /PRNewswire/ - Demers Ambulances announces its first delivery in the state ... County Emergency Medical Services (EMS) consisting of four ... van. Quality Emergency Vehicles in Lecanto, FL ... This is the latest in Demers, ongoing expansion of sales.  ... Demers. --> Benoit LaFortune , Executive Vice President ...
(Date:2/12/2016)... Feb. 12, 2016   HeartWare International, Inc . ... and webcast to discuss its financial results for the ... Thursday, February 25, 2016 at 8:00 a.m. ET.  The ... the conference call and webcast.  On the conference call ... highlights from the fourth quarter and business outlook.   ...
(Date:2/12/2016)... Kalifornien, 12. Februar 2016  Sequent Medical, Inc. ... von Patienten für eine Studie zur Sicherheit und ... speziell für die Behandlung von rupturierten intrakraniellen Aneurysmen ... Leiter der Neuroradiologie an der Universitätsklinik Bicètre in ... der CLARYS-Studie hat den ersten Patienten aufgenommen. ...
Breaking Medicine Technology:
(Date:2/13/2016)... ... ... With FCPX Overlay Embers from Pixel Film Studios users can now apply ... user can select from up to 40 effect overlays. With FCPX Overlay Embers users ... value, contrast, glow, and more all within a click of a mouse. , ...
(Date:2/13/2016)... , ... February 13, 2016 , ... ... of Nursing with an in-kind gift of a VeinViewer® Vision vein finder ... they learn how to start an IV and draw blood, combining technology with ...
(Date:2/13/2016)... (PRWEB) , ... February 13, 2016 , ... ... Tech Outlook’s top Clinical Data Management Solution Providers list for its expertise in ... functional and domain expertise to serve the technology needs of global clients. DDi ...
(Date:2/12/2016)... ... February 12, 2016 , ... The law firm of Morrow, Morrow, Ryan ... The purpose of these scholarships is to encourage applicants to pursue a degree in ... within these two parishes. , “We have available jobs in St. Landry and ...
(Date:2/12/2016)... Falls Church, VA (PRWEB) , ... February 12, 2016 , ... CDRH Enforcement Trends: , ... http://www.fdanews.com/cdrhenforcementtrends , As Winston Churchill said, “Those who don’t learn ... 2015 will show what to expect when they come knocking this year. But that takes ...
Breaking Medicine News(10 mins):