Navigation Links
Cepheid Receives FDA Clearance for First On-Demand Molecular Diagnostic Test for Clostridium difficile Infection
Date:7/13/2009

SUNNYVALE, Calif., July 13 /PRNewswire-FirstCall/ -- Cepheid (Nasdaq: CPHD) today announced it has received clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert(R) C. difficile test, an on-demand molecular diagnostic test designed for 45-minute detection of the bacterium that causes Clostridium difficile infection (CDI). The Xpert C. difficile test is the first test for CDI to deliver both rapid turnaround and a high degree of accuracy.

"The previous lack of an accurate and rapid diagnostic test for CDI has greatly impeded our ability to halt the increasing rate of CDI, which has taken a severe turn in the past several years. Patients can have their first diarrhea symptoms on a Monday and be dead by Thursday," said Dale Gerding, MD, professor of medicine, division of infectious diseases, Loyola University Chicago Stritch School of Medicine. "Toxigenic culture offers high sensitivity, but laboratories find it burdensome and far too slow for practical diagnostic use. Instead, many use less labor-intensive toxin EIA (enzyme immunoassay) and GDH (glutamate dehydrogenase) tests, which fail to detect 20-50% of cases. From a practical standpoint, this means many patients are not subjected to proper isolation procedures that can curtail transmission of C. difficile. A rapid, accurate CDI test will eliminate needless repetitive testing and enable us to implement appropriate treatment and infection control measures faster in our battle against this devastating Healthcare Associated Infection."

C. difficile, a spore-forming bacterium, is now challenging Methicillin-resistant Staphylococcus aureus (MRSA) as the most prevalent Healthcare Associated Infection (HAI) in the United States. A recent study published by the Association for Professionals in Infectio
'/>"/>

SOURCE Cepheid
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine news :

1. Cepheid Announces European Release of Improved Test for BCR-ABL Chromosomal Translocation Associated With Chronic Myelogenous Leukemia (CML)
2. Cepheid Announces Symposium Program for 2009 Association for Professionals in Infection Control (APIC) Annual Conference
3. Cepheid Receives Health Canada License for Xpert(R) HemosIL(R) FII & FV Test
4. Blue Mountain Quality Resources Announces that Cepheid has Selected Blue Mountain Regulatory Asset Manager
5. Cepheid to Webcast Upcoming Financial Presentations
6. Cepheid Announces European Release of First On-Demand Molecular Pre-Surgical Screening Test for Simultaneous Detection of Methicillin-Sensitive and Resistant S. aureus
7. Cepheid Receives Health Canada License for First On-demand Diagnostic Test for Life-threatening MRSA and S. aureus Infections From Patient Positive Blood Culture Bottles
8. Cepheid Reports Fourth Quarter and Full Year 2008 Results
9. Cepheid Receives Health Canada License for First Molecular Diagnostic Test for MRSA and S. aureus Soft Tissue Infections
10. Cepheid Launches First On-Demand Molecular Diagnostic Test for Clostridium Difficile Into European Market
11. Cepheid Signs Group Purchasing Contract With Premier Healthcare Alliance, One of the Largest U.S. Group Purchasing Organizations
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/9/2014)... associated with a small increased risk of prostate cancer, ... cancer according to a new study from Harvard School ... association remained even among men who received regular PSA ... be explained by diagnostic bias. It is the largest ... the link between vasectomy and prostate cancer. , The ...
(Date:7/9/2014)... CHICAGO After Susan Wakulich was told she had an ... lay ahead of her. , "I was devastated," said Wakulich, ... suburbs. "I knew this was a serious diagnosis. Then I ... trial that involved a less invasive procedure. It was something ... is participating in a multi-center U.S. clinical trial to evaluate ...
(Date:7/9/2014)... that captures heretofore hidden ways that cells are regulated, ... makes breast cancer cells more likely to metastasize. , ... in part by blocking two other proteins that are ... two disease processes could have unexpected ties. , ... of Nature , points to the possibility of ...
(Date:7/9/2014)... scientific research into the metabolism of stromal support cells ... metabolism of these cell types in the development of ... inflammatory conditions and cancer. That was the conclusion of ... Leuven in the leading journal Nature . , ... of wake-up call. The metabolism of cancer cells has ...
(Date:7/9/2014)... R.I. Researchers have found that fecal transplantation ... in immunocompromised patients. This is the result of ... in the Center for Women,s Gastrointestinal Medicine at The ... been published online in advance of print in the ... difficile , or C. diff , has increased ...
Breaking Medicine News(10 mins):Health News:Vasectomy may increase risk of aggressive prostate cancer 2Health News:New type of stent could help some brain aneurysm patients 2Health News:Protein pushes breast cancer cells to metastasize 2Health News:Protein pushes breast cancer cells to metastasize 3Health News:Wake-up call for more research into cell metabolism 2Health News:Women's Medicine Collaborative examines safety of fecal transplant to treat C. difficile 2
... conditions are likely to change their preferences for receiving ... to new findings. The study, which will ... in Amsterdam today (26 September 2011), suggests that different ... but this will often go unnoticed by their healthcare ...
... new study has shown that people with chronic obstructive ... are at a serious risk of developing cardiovascular disease. ... September 2011) at the European Respiratory Society,s Annual Congress ... lung function should be routinely screened for cardiovascular disease, ...
... a phase III clinical trial have shown that ... women with advanced breast cancer resistant to hormonal ... European Multidisciplinary Cancer Congress [1] that women treated ... an improved progression-free survival of nearly seven months ...
... Reporter , FRIDAY, Sept. 23 (HealthDay News) -- Many studies ... a day is heart-healthy, and much of the benefit has ... red wine called polyphenols. But a new Dutch study ... not lower blood pressure after all. Study author ...
... trial comparing tamoxifen with the aromatase inhibitor letrozole ... of time and continues to prevent breast cancer ... post-menopausal women with hormone receptor-positive early breast cancer. ... 2011 European Multidisciplinary Cancer Congress [1], in Stockholm ...
... The Netherlands: Belly fat, known clinically as central obesity, has ... study. The findings, which will be presented at the ... 2011), have shown central obesity as a risk factor for ... a number of health effects, such as diabetes and heart ...
Cached Medicine News:Health News:Study shows decisions over life-sustaining treatment are likely to change 2Health News:New evidence highlights risk of comorbidities for COPD patients 2Health News:New hope for advanced post-menopausal breast cancer patients resistant to hormonal therapy 2Health News:Antioxidants Not Behind Red Wine's Healthy Effect on Heart: Study 2Health News:Aromatase inhibitor letrozole guards against breast cancer relapse for up to 8 years 2Health News:Aromatase inhibitor letrozole guards against breast cancer relapse for up to 8 years 3Health News:Aromatase inhibitor letrozole guards against breast cancer relapse for up to 8 years 4Health News:'Belly fat' linked to development of asthma 2
(Date:1/15/2014)... Calif. , Jan. 15, 2014 Massachusetts ... (NASDAQ: AMGN ) announced today that ... discover and validate new therapeutic targets and develop ... chronic disorder that affects millions worldwide. The MGH-Broad-Amgen ...
(Date:1/15/2014)...  In an unprecedented effort to curb the spread of "superbugs" such ... vehicles, an advanced and portable UV germicidal lamp manufactured by MRSA-UV ... In order to prevent EMS paramedics and transport ... West Palm Beach Fire Rescue is the first in ...
(Date:1/15/2014)... , Jan. 15, 2014  According to Millennium ... technology market intelligence, the United States ... (TEO) device markets will expand moderately through 2022, ... segments. In particular, increasing interest in drug-eluting beads ...
Breaking Medicine Technology:Mass. General, Broad Institute and Amgen Will Work to Discover New Drugs for Inflammatory Bowel Disease 2Mass. General, Broad Institute and Amgen Will Work to Discover New Drugs for Inflammatory Bowel Disease 3Mass. General, Broad Institute and Amgen Will Work to Discover New Drugs for Inflammatory Bowel Disease 4Superbugs No Longer Ride In Rescue Vehicles 2US and European Transcatheter Embolization and Occlusion Device Market to Surpass $1.6 Billion by 2022 2US and European Transcatheter Embolization and Occlusion Device Market to Surpass $1.6 Billion by 2022 3
... May 18, 2011 The Consumer Healthcare Products ... acetaminophen medicines for children, applauds the U.S. Food ... and caregivers give their children the right amount ... Committee and Pediatric Advisory Committee recommended enhancing the ...
... Kinetics, Inc. (NKI) ( www.neuro-kinetics.com ), manufacturers of ... neuro-otologic, vestibular and neurological testing, said today that ... control and analysis software. Clinical specialists ... conduct vestibular, oculomotor and optokinetic tests to detect ...
Cached Medicine Technology:OTC Industry Supports FDA Advisory Committee Recommendations on New Dosing Instructions 2OTC Industry Supports FDA Advisory Committee Recommendations on New Dosing Instructions 3Neuro Kinetics Releases Updated Version of Neuro-Otologic Control and Analysis Software 2
... Intended for the quantitative determination ... Reaction: kinetic, lag phase of ... by linear phase of at ... nm. Linearity: 100 mg/dL (35.6 ...
For the quantitative determination of Urea Nitrogen in serum. Linearity: 80 mg/dl. Reaction measured at 340 nm....
Intended for the quantitative determination of total bilirubin in serum. Modified evelynmalloy method. Endpoint reaction. Wavelength: 555 nm. Linearity: 20 mg/dl (340 mol/l)...
... Powerwave is the first microplate spectrophotometer designed ... 7 days per week. With rugged hardware, ... Powerwave breaks the barrier of traditional spectrophotometry ... One instrument can easily read up to ...
Medicine Products: