Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Nanosphere Obtains FDA Clearance For C. Difficile Test - Quick Facts

Nanosphere Inc. (NSPH: Quote) announced the U.S. Food and Drug Administration or FDA granted 510(k) clearance permitting marketing of its C.difficile test on the automated sample-to-result Verigene System.

The C. difficile test expands Nanosphere's infectious disease test capabilities. C. difficile infection is a cause of diarrhea that can lead to colitis, other serious intestinal conditions and death. In less than two hours, the C. difficile test detects the toxin A and B gene sequences of C. difficile and identifies the PCR ribotype 027 strain which is associated with increased severity of disease and used for infection control. Early and accurate diagnosis of C. difficile infections is critical in both the proper treatment of infected patients and subsequent implementation of isolation and containment procedures to prevent further spread of the infection.

The sample-to-result test automates the steps of bacterial DNA extraction, amplification, hybridization and target detection on the Verigene System. The ease-of-use and rapid turnaround time of the test allow hospitals of any size to benefit from the speed and accuracy of automated molecular testing. Nanosphere plans to commercialize the enteric pathogens and gram-negative tests in 2013 following receipt of the necessary regulatory approvals.

Register
To receive FREE breaking news email alerts for Nanosphere, Inc. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
The Swiss economy stalled in the second quarter as the improvement in household spending was insufficient to offset the weakness in exports and investment in construction. Gross domestic product remained flat from the first quarter, when it accelerated to 0.5 percent, the State Secretariat for Economic Affairs said Tuesday. Economists had expected GDP to rise 0.5 percent in the second quarter. Policymakers of Reserve Bank of Australia decided to maintain its record low interest rate once again as they continue to assess that the most prudent course is a period of stability in interest rates. The monetary policy board retained the cash rate at 2.50 percent. The rate has been at the current level since August 2013. A ban on athletes using stamina-boosting gases - xenon and argon - came into effect on Monday. The World Anti-Doping Agency (WADA) said Hypoxia-Inducible Factor (HIF) activators Xenon and Argon have been added to the 2014 List of Prohibited Substances and Methods List following the required three-month notice period and UNESCO's communication to all States Parties. A recommendation to revise the
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.