logo
Share SHARE
FONT-SIZE Plus   Neg

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

Nanosphere Inc. (NSPH) 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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Dutch consumer electronics giant Philips Electronics NV reported Monday lower attributable net income in its third quarter, while pre-tax income increased. Sales were flat on a reported basis, but grew 4 percent on a comparable basis mainly on growth in China. Further, the company said its outlook for 2017 remains unchanged despite ongoing global uncertainties. 10 Worst Places To Raise A Family Whether you are a young couple building a nest or seasoned parents looking for a change of scenery, there are number of places around the country that should be avoided, according to personal finance website WalletHub. They looked at mainly five categories for... A passenger has filed a lawsuit against Canadian budget airline Sunwing Airlines for serving him cheap sparkling wine instead of champagne on board a flight, according to media reports. The Canadian passenger, Daniel MacDuff, reportedly boarded his Sunwing flight to Cuba in February, on a flight package that advertised a complimentary on-board champagne toast.
comments powered by Disqus
Follow RTT