logo
Share SHARE
FONT-SIZE Plus   Neg

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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Computer and printer maker Hewlett-Packard Co. said Thursday after the markets closed that its second quarter profit fell 21% from last year, hurt by lower revenue and costs related to the planned separation of the company. However, the company's quarterly earnings per share, excluding items, came in above analysts' expectations, but its quarterly revenue fell short of analysts' forecast. Accounting software maker Intuit reported a plunge in third-quarter profit, hurt by impairment charges, even as results topped Wall Street estimates, driven by growth in small business segment amid a strong tax season. Struggling teen-apparel retailer Aeropostale Inc. (ARO), Thursday said its first-quarter loss narrowed from a year ago, driven largely by stronger margins even as revenues continued to plunge dropped. Nevertheless, the company lost almost one-fifth of its market value in after-hours trade, with the...
comments powered by Disqus
Follow RTT