Navigation Links
FDA Clears Test for Bacteria That Can Cause Serious Intestinal Disease

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.


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

FDA: Device Approvals and Clearances

CDC: Prevent Clostridium difficile Infection

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,
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:
(Date:10/13/2015)... VEGAS , Oct. 13, 2015 VIVA ... of vascular medicine and intervention through education and research, ... annual conference,  VIVA 2015 . Sixteen trial results, featuring ... released for the first time on Monday and Tuesday, ... --> --> Since ...
(Date:10/13/2015)... , Oct. 13, 2015  Kay Elledge, ... and Fellow American College of Obstetrics and Gynecology ... evolve by establishing the Genuine Self Medical Laser ... and men.  In recognition of Breast Cancer ... special promotion for MonaLisa Touch treatments ...
(Date:10/13/2015)... PITTSBURGH , Oct. 13, 2015  Mylan N.V. (Nasdaq: ... at 5:00 p.m. ET host a conference call and webcast ... Company plc (NYSE: PRGO ; TASE) shareholders through Mylan,s ... by Mylan,s Executive Chairman Robert J. Coury , CEO ... --> --> Mylan ...
Breaking Medicine Technology:
(Date:10/13/2015)... (PRWEB) , ... October 13, 2015 , ... ... hold the festivities in the friendly confines of their home. Whether it's making ... neighbors, try these Halloween recipes from Florida Dairy Farmers. , Recipe 1: ...
(Date:10/13/2015)... ... 2015 , ... Boulder native and lifelong athlete, Mark Gonglach, ... Tested by Olympic and professional athletes, he developed the combined massage and vibration ... sporting equipment and high-tech sales led him to transition from Rally Software to ...
(Date:10/13/2015)... ... October 13, 2015 , ... CURE Media ... today announced a new partnership with the International Waldenstrom’s Macroglobulinemia Foundation (IWMF) ... non-Hodgkin’s lymphoma, their families and physicians. , “Waldenstrom’s Macroglobulinemia is a so-called ...
(Date:10/13/2015)... ... 13, 2015 , ... According to an article published October 5th ... who successfully lose weight with a bariatric procedure are much less likely to develop ... notes that anywhere from 40 to 50 percent of all endometrial cancer cases are ...
(Date:10/13/2015)... ... October 13, 2015 , ... In an age where the ... 36 percent lower per square foot than in 2009. The Williamsport Regional Medical Center ... and cooling has decreased by eight percent. , According to Facilities Management Administrative ...
Breaking Medicine News(10 mins):