Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

FDA Grants Clearance To Quest Diagnostics' Simplexa C. Difficile Molecular Test

RELATED NEWS
Trade DGX now with 

Quest Diagnostics (DGX: Quote) announced that the U.S. Food and Drug Administration has granted 510(k) clearance to its Simplexa C. difficile Universal Direct Test on the 3M Integrated Cycler.

The test, from the company's Focus Diagnostics business, is intended to aid in the diagnosis of Clostridium difficile-associated disease. It uses a proprietary technique to eliminate the time consuming nucleic-acid sample extraction process required by many other molecular tests, for potentially faster results reporting for hospitals and clinical laboratories.

Simplexa tests, running on the 3M Integrated Cycler, employ real-time polymerase chain reaction (RT-PCR) to qualitatively detect viruses, bacteria and other analytes. The Simplexa C. difficile Universal Direct test is performed on liquid or unformed human stool samples and detects the toxin B gene (tcdB) of C. difficile, including NAP1.

C. difficile-associated disease is a common and sometimes fatal healthcare-associated infection that causes diarrhea and other intestinal problems.

The company said that the Simplexa C. difficile Universal Direct Test on the 3M Integrated Cycler is immediately available in the United States. Focus Diagnostics launched the test in Europe during the second quarter of 2011.

Register
To receive FREE breaking news email alerts for Quest Diagnostics and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
The Philippine economy grew more-than-expected in the second quarter on strong support from foreign demand, figures from the National Statistical Coordination Board showed Thursday. Gross domestic product for the second quarter advanced 6.4 percent year-on-year, exceeding economists' expectation for 6.1 percent growth. This followed by a revised 5.6 percent rise seen in the first quarter. Hewlett-Packard has recalled the AC power cords for its HP and Compaq notebook computer, citing a tendency to overheat, causing a potential fire and burn hazard. HP requests that consumers stop using the cord immediately and contact them to order a replacement cord free of charge. A UN report describing terrible atrocities carried out by Islamic State militants in Syria says children as young as 10 are being recruited and trained at ISIS camps as fighters. The report, based on 480 interviews and and evidence collected between 20 January and 15 July, chronicles the unimaginable brutality and human cost of the Syrian conflict. The report by the independent international com
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.