Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Roche Submits TnT-hs Assay For Clearance On Cobas Immunoassay, Elecsys Analyzers

Roche (RHHBY.PK) announced that it has filed a 510(k) submission to the U.S. Food and Drug Administration or 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, the company said.

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, the company said.

Click here to receive FREE breaking news email alerts for Roche Holding AG and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Toyota Motor Corp. (TM, TYT.L) Thursday announced 1.1 percent decline in worldwide production for October, as there was a sharp decline in production of passenger cars in Japan. Production outside Japan improved 2.3 percent. In a separate announcement, the Japanese automaker said it will recall more... Computer and printer maker Hewlett-Packard Co. said Tuesday after the markets closed that its fourth quarter profit fell 6% from last year, as revenue declined 2%. The company's quarterly earnings per share, excluding items, came in line with analysts' expectations, but its quarterly revenue fell short of analysts' forecast. This organic and natural products company has experienced strong compounded annual growth over the last four fiscal years with its net sales growing 25% and adjusted income from continuing operations over 30%.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.