Roche submits TnT-hs assay to FDA for clearance on the cobas immunoassay and Elecsys analyzers
Roche High Sensitivity Troponin T assay would meet the diagnostic goals set by the Universal Definition of Myocardial Infarction (MI). The advantages of this test include improved analytical imprecision at concentrations below the 99th percentile of normal and high sensitivity
INDIANAPOLIS, June 7, 2012 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has filed a 510(k) submission to the U.S. Food and Drug Administration (FDA) for a fully automated TnT-hs assay for use on Roche's full portfolio of laboratory analyzers.* Intended as an aid in the in the diagnosis of myocardial infarction, the electrochemiluminescence (ECL) immunoassay is used for the in vitro quantitative determination of TnT-hs in human serum and plasma.
Roche Diagnostics offers a full selection of cardiac tests in its portfolio: Troponin T (TnT), Troponin I (TnI), NT-proBNP, CK-MB, Myoglobin and D-Dimer. The combination of a full cardiac menu with the lowest time of analysis on the market (STAT assay of only 9 minutes), the broadest integrated menu and ECL technology allows the Roche total solution to inspire confidence in the laboratory environment.
The assay is designed for use on all Roche immunoassay systems for low-, mid- and high-volume testing environments. The FDA has a 90-day period after the 510(k) submission for substantive review of the application.
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 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 42.5 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.
*This product is not cleared or available for use in the U.S. A 510(k) submission is pending.
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Vice President, Commercial Education and Communications
Roche Diagnostics Corporation
SOURCE Roche Diagnostics
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