Roche Diagnostics Corporation Introduces Full Line of 9-Minute STAT Assays for Cardiac Biomarker Testing on cobas 6000 Analyzer Series

INDIANAPOLIS, Sept. 16 /PRNewswire/ -- Roche Diagnostics (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has introduced a complete battery of STAT immunoassays for cardiac biomarker testing on the cobas® 6000 analyzer series, an integrated system designed for diagnostic labs with medium testing volumes. With a 9-minute duration, the assays are faster than any other cardiac immunoassay tests currently available on an integrated platform and enable labs to deliver results to doctors treating cardiac patients in about half the time of standard Roche tests. The tests complement a line of existing STAT cardiac assays for Roche's stand-alone platform, the cobas 4000 series.

"In critical care environments that require rapid decision-making, this new line of STAT assays can help healthcare facilities meet current cardiac care turnaround time guidelines," said Hans-Juergen Loyda, Ph.D., MBA, director of clinical development and education at Roche Diagnostics Corporation. "Making the tests available on the cobas 6000 series gives labs the option to run Roche STAT assays on either stand-alone or integrated platforms."

The new 9-minute STAT immunoassay tests include troponin T, troponin I, CK-MB, myoglobin and NT-proBNP and run on the cobas e 601 analyzer, part of the cobas 6000 analyzer series, an integrated platform that offers both clinical chemistry and immunoassay testing. The STAT tests are virtually equivalent to Roche's 18-minute tests in performance, precision and sensitivity.

The cardiac STAT assays can all be run with one simple blood draw via the Roche OneTUBE solution, which consists of a single lithium heparin tube that can be run on any of Roche's integrated platforms. By allowing a single technician to process a single draw from a single point of entry instead of drawing multiple tubes for cardiac tests on multiple analyzers, the OneTUBE solution helps to simplify sample handling and reduce the need for sample splitting.

About Cardiac Critical Care Guidelines

The National Association of Clinical Biochemistry (NACB) recommends that cardiac biomarker testing should have a turnaround time (TAT) of less than 60 minutes optimally 30 minutes.(1) A conventional biomarker panel for patients presenting with shortness of breath includes troponin, CK-MB, myoglobin, D-dimer and NT-proBNP.(2) In addition, a cardiac biomarker test TAT of 30 minutes or less is required for a facility to be accredited as a Chest Pain Center by the Society of Chest Pain Centers.(3)

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 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.

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1 Storrow AB, Apple FS, Wu AH, Jesse R, Francis G, Christenson RH. Use of cardiac biomarkers for acute coronary syndromes. In: Laboratory medicine practice guidelines: evidence-based practice for point-of-care testing. Washington (DC): National Academy of Clinical Biochemistry (NACB); 2006. p. 13-20. Accessed September 2010 at: http://www.guideline.gov/content.aspx?id=10813.

2 Singer AJ, Thode HC Jr, Green GB et al. The incremental benefit of a shortness-of-breath biomarker panel in emergency department patients with dyspnea. Acad Emerg Med. 2009 Jun;16(6):488-94.

3 Peacock WF, Fonarow GC, Ander DS et al. Society of Chest Pain Centers recommendations for the evaluation and management of the observation stay acute heart failure patient. A report from the society of chest pain centers acute heart failure committee. Acute Cardiac Care. 2009;11:1,3-42.

SOURCE Roche Diagnostics, Inc.