Navigation Links
FDA Clears Test for Bacteria That Can Cause Serious Intestinal Disease
Date:4/8/2011

SILVER SPRING, Md., April 8, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today cleared a test called the Cepheid Xpert C. difficile/Epi assay that is designed to rapidly detect the toxin B gene associated with Clostridium difficile infection (CDI), a cause of diarrhea that can lead to colitis, other serious intestinal conditions and death in severe cases.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

Clostridium difficile (C. difficile) bacteria are found in the stool of an infected person. Others can become infected if they touch items or surfaces contaminated with the bacteria or spores and then touch their mouth.

The Cepheid Xpert C. difficile/Epi assay is automated and works on the Cepheid GeneXpert Dx System to detect toxin gene sequences associated with toxigenic C. difficile. The Cepheid GeneXpert Dx System consists of an instrument that houses single-use disposable cartridges, a personal computer, and software that allow a laboratory technician to run tests and view test results quickly.

The test, Cepheid Xpert C. difficile/Epi assay, determines if C. difficile is in a patient's stool and also detects if the C. difficile is the epidemic 027/NAP1/BI strain, which has been associated with a marked increase in the severity and incidence of CDI in North America and Europe over the past decade.

The test is intended for use as an aid in the diagnosis of CDI. The detection of the 027/NAP1/B1 strain is for epidemiological purposes only and should not be used to determine or monitor treatment. Health care facilities should monitor the number of C. difficile infections and, especially if rates at the facility increase, the severity of disease and patient outcomes.

"Health care professionals in the infectious disease community who have seen various outbreaks of CDI associated with aggressive strains in recent years now have a new testing tool to detect this disease," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics Device Evaluation and Safety in the FDA's Center for Devices and Radiological Health.

People at risk of developing the bacterial infection include the elderly, patients in hospitals or living in a nursing home, and people taking antibiotics for another infection. The most effective way to prevent CDI is thorough hand-washing with soap and warm water.

The Cepheid Xpert C. difficile/Epi test is made by Cepheid of Sunnyvale, Calif.

For more information:

FDA: Medical Devices

http://www.fda.gov/MedicalDevices/default.htm

FDA: Device Approvals and Clearances

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm

CDC: Prevent Clostridium difficile Infection

http://www.cdc.gov/Features/Clostridiumdifficile/

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Clears Advanced Test for Monitoring Metastatic Colorectal Cancer
2. FDA Clears ExAblate Fertility Enhancement Study in Women With Uterine Fibroids
3. FDA Clears the Pathwork(R) Tissue of Origin Test for Hard-To-Identify Tumors
4. U.S. Food and Drug Administration Clears Way for Multi-Center Clinical Trial of IDEV Technologies SUPERA Peripheral Stent
5. FDA Clears a Test for Ovarian Cancer
6. Private Investment Firm Czura Thornton Today Introduces Clearstone Central Laboratories as the Newest Member of the Czura Thornton Life Science Group
7. U.S. Food and Drug Administration Clears Alcatel-Lucent Remote Patient Monitoring Solution for Sale in the United States
8. FDA Clears the First Rapid Test to Detect Bacteria in Pooled Platelets
9. FDA Grants Cequent IND - Clears Way for First-Ever Clinical Trial of Orally Delivered RNAi Therapeutic: CEQ508, a tkRNAi Drug Candidate in Oncology
10. FDA Clears the Fenwal Amicus(R) Separator System for Collecting Platelets in New Additive Solution
11. FDA Clears Three Additional Antimicrobials for Use on TREK Sensititre(R) In Vitro Diagnostic (IVD) MIC Susceptibility Plates: Minocycline and Telavancin Used to Treat MRSA and Other Infections; and Tigecycline, Now Cleared for Streptococcus Pneumoni
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/24/2017)... Feb 24, 2017 Research and Markets has announced ... - 2016" report to their offering. ... The latest research Dry eye Drugs Price Analysis and ... Dry eye market. The research answers the following questions: ... and their clinical attributes? How are they positioned in the Global Dry ...
(Date:2/24/2017)... 2017 Juan Monteverde , founder and ... a boutique securities firm headquartered at the Empire State ... announces that a class action lawsuit has been filed in ...  against Inotek Pharmaceuticals Corporation (NASDAQ:  ITEK)("Inotek" or the "Company") ... 23, 2015 and December 30, 2016, inclusive (the "Class ...
(Date:2/24/2017)... ITL Limited, ( ASX : ITD ), une ... d,annoncer les excellents résultats semestriels clos le 31 décembre ... présentation complète « Résultats et mise à jour sur la ... Faits marquants ... $ ; en hausse de 104 %) Bénéfice ...
Breaking Medicine Technology:
(Date:2/24/2017)... ... 24, 2017 , ... Dr. Ronald E. Hawkins, vice president ... of Peter A. Bell, DO, MBA, HPF, FACOEP-dist., FACEP, as the new dean ... Dr. Bell comes to Liberty from the Ohio University Heritage College of Osteopathic ...
(Date:2/24/2017)... ... 2017 , ... Healthcare Associates of McKinney announced today that they ... 8080 State Highway 121, Suite 210, McKinney, Texas 75070. It is in the ... As the practice has grown, the need for more space has been paramount. ...
(Date:2/24/2017)... ... 24, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The House of ... generation. Yisrayl makes an astounding statement when he says that the entire Bible ... Bible details the current times so plainly that anyone should be able to see ...
(Date:2/24/2017)... ... February 24, 2017 , ... Rosica Communications, a national ... leadership , media relations, social media, content marketing and SEO, is now offering ... Act-On, an intuitive marketing automation platform. , Rosica will now offer the platform ...
(Date:2/23/2017)... ... February 23, 2017 , ... On February 22, 2017 ... letter to withdraw previous guidance issued by the Obama Administration requiring schools ... in May 2016 by the Obama Administration came in response to a growing ...
Breaking Medicine News(10 mins):