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 out
'/>"/>

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

Page: 1 2

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:10/31/2014)... , Oct. 31, 2014  Semler Scientific, ... emerging medical risk assessment company that develops patented ... and evaluating chronic diseases, today reported financial results ... September 30, 2014. "In the ... Doug Murphy-Chutorian , M.D., chief executive officer ...
(Date:10/31/2014)... Therapeutics, Inc. (NYSE MKT: MSTX), a clinical-stage biopharmaceutical company, ... 30, 2014. Brian M. Culley, the ... productive for Mast. Consistent with prior guidance, our 388-patient pivotal ... is on track to complete enrollment by the end ... in the U.S. and more than ten study sites ...
(Date:10/31/2014)... Mich. , Oct. 31, 2014  Lycera ... modulators to treat autoimmune disease and cancer, today ... novel synthetic RORgamma agonist product candidates will be ... for Immunotherapy of Cancer (SITC) being held November ... Convention Center, National Harbor, MD.  The poster, entitled ...
Breaking Medicine Technology:Semler Reports Third Quarter 2014 Financial Results 2Semler Reports Third Quarter 2014 Financial Results 3Mast Therapeutics Reports Third Quarter 2014 Financial Results 2Mast Therapeutics Reports Third Quarter 2014 Financial Results 3Mast Therapeutics Reports Third Quarter 2014 Financial Results 4Mast Therapeutics Reports Third Quarter 2014 Financial Results 5Mast Therapeutics Reports Third Quarter 2014 Financial Results 6Mast Therapeutics Reports Third Quarter 2014 Financial Results 7Mast Therapeutics Reports Third Quarter 2014 Financial Results 8Lycera Announces Presentation of Data on Anti-Tumor Activity of Novel Synthetic RORgamma Agonists at Society for Immunotherapy of Cancer Meeting 2
... 29, 2010 Reportlinker.com announces that a new ... 2010-2015 In-depth Research Report on ... http://www.reportlinker.com/p0356862/2010-2015-In-depth-Research-Report-on-China-Sodium-Fluoride-Industry.html Report SummaryBased on ... Bureau, General Administration of Custom, Ministry of Commerce ...
... Reportlinker.com announces that a new market research report ... The Outlook for Pharmaceuticals to 2012 ... Pharmaceuticals to 2012 is a new collection of management ... individual and highly-detailed analysis of each market, looking at ...
Cached Medicine Technology:Reportlinker Adds 2010-2015 In-depth Research Report on China Sodium Fluoride Industry 2Reportlinker Adds E7: The Outlook for Pharmaceuticals to 2012 2Reportlinker Adds E7: The Outlook for Pharmaceuticals to 2012 3Reportlinker Adds E7: The Outlook for Pharmaceuticals to 2012 4Reportlinker Adds E7: The Outlook for Pharmaceuticals to 2012 5
(Date:10/31/2014)... 2014 Daily Gossip writes in its Xtreme ... as the fastest fat loss program ever developed. It promises ... month. , There is no wonder after all that this ... time. The new nutrition and workout fat loss program was ... , According to the author of this fat loss ...
(Date:10/31/2014)... At the start of 2014, numerous news ... monoxide poisoning in their homes. Now, as 2015 (and ... Missouri-based heating and cooling company is taking a more ... the home heating season with the assurance that their ... Nov. 1, 2014, E and Q Heating and Cooling ...
(Date:10/31/2014)... 31, 2014 Energy Textiles has recently ... new gear is now available online, and Energy Textile ... of Celliant infrared-active athletic gear over compression gear. , ... contract has been signed for Under Armour to provide ... next eight years. In light of this decision, Energy ...
(Date:10/31/2014)... Oct. 31, 2014 (HealthDay News) -- Obesity increases the ... black and Hispanic women, two new U.S. studies show. ... found being overweight or obese increased the risk for ... women. "We,ve known this for a long time ... also in Hispanic women," study author Esther John, a ...
(Date:10/31/2014)... four older Americans say that either they or a ... according to the latest issue of The Gerontological Society ... ( PP&AR ), which goes on to show that ... to honor patients, end-of-life health care wishes. , This ... and Options ," features 12 articles that present new ...
Breaking Medicine News(10 mins):Health News:Xtreme Fat Loss Diet Review Reveals How to Transform Your Body in 25 Days 2Health News:Many Homeowners Missing Key Safety Risks with Home Heating;Missouri-based Company E and Q Announces New Safety Check 2Health News:Many Homeowners Missing Key Safety Risks with Home Heating;Missouri-based Company E and Q Announces New Safety Check 3Health News:Compression Gear--Is There a Better Alternative? 2Health News:Compression Gear--Is There a Better Alternative? 3Health News:Compression Gear--Is There a Better Alternative? 4Health News:Study Confirms Obesity-Breast Cancer Link for Blacks, Hispanics 2Health News:Advance directives can benefit patients, families, and health care system 2
... patient,s DNA may lead to routine gene scans, experts ... In a genetics first, researchers report that they have ... acute myelogenous leukemia. , There were some surprises -- ... genetic alterations, were associated with the blood cell cancer. ...
... The Medical College of Georgia announced today that it ... the Bill & Melinda Gates Foundation. The grant ... by Dr. Pandelakis A. Koni titled "Antibody-Dependent Cellular Cytotoxicity ... is one of 104 grants recently announced by the ...
... 5 Dialysis Corporation,of America (Nasdaq: DCAI ... secured,revolving credit facility with KeyBank National Association to ... agreement provides for both,base rate and LIBOR loans ... the bank,s base rate or the London InterBank ...
... WEXFORD, Pa., Nov. 5 Millennium Pharmacy Systems, ... Health Care Center in,Bridgeport, West Virginia, its first ... more than 100 facilities in four states: Pennsylvania,Maryland, ... Administrator, states, "The Millennium,system was more advanced than ...
... founded a state-of-the-art eye care facility in Tanzania ... BERKELEY, Calif., Nov. 5 Today, Seva,Foundation ... in,the fight against preventable blindness around the world ... Yesterday, the Kilimanjaro Center for Community Ophthalmology (KCCO),which ...
... The American Heart,Association and its Pharmaceutical Roundtable ... Research Centers initiative. The project,will provide a network ... results, or outcomes, of healthcare for people with ... The initiative is supported in part by a ...
Cached Medicine News:Health News:First-Ever Mapping of Cancer Patient's Genome 2Health News:First-Ever Mapping of Cancer Patient's Genome 3Health News:MCG receives $100,000 Grand Challenges Explorations grant for innovative global health research 2Health News:Dialysis Corporation of America Announces $25 Million Credit Facility 2Health News:Millennium Pharmacy Systems Expands into West Virginia 2Health News:Seva Foundation Recognizes Paul Courtright and Susan Lewallen for Their Commitment to Blindness Prevention 2Health News:Seva Foundation Recognizes Paul Courtright and Susan Lewallen for Their Commitment to Blindness Prevention 3Health News:Four Medical Centers Awarded Funds to Improve Outcomes Research for Heart Disease and Stroke 2
Toxoplasma IgM II ELISA....
HSV 1 & HSV 2 DFA Test....
Herpes Simplex Virus 2 IgG ELISA....
Herpes Simplex Virus 1 IgG ELISA....
Medicine Products: