Navigation Links
BD Announces FDA 510(k) Clearance of Novel Molecular Assay to Diagnose Clostridium difficile Infections

SAN DIEGO, Jan. 12 /PRNewswire-FirstCall/ -- BD Diagnostics, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), announced today it has received clearance from the U.S. Food and Drug Administration to market the BD GeneOhm(TM) Cdiff molecular assay for the rapid detection of the Toxin B gene found in toxigenic Clostridium difficile, the bacterial pathogen responsible for Clostridium difficile infection (CDI). It is the first CDI molecular diagnostic that offers sensitivity, simplicity and speed in one test procedure.

"The BD GeneOhm Cdiff assay provides a simple and rapid stool test with excellent sensitivity and specificity that allows same-day identification of toxigenic Clostridium difficile," said Thomas Davis, M.D., Ph.D., Professor, Pathology and Laboratory Medicine at the Indiana University School of Medicine, and Pathologist with Wishard Health Services and Clarian Health laboratories. "This test should improve patient care because it gives labs the option of a single assay that will markedly reduce or even eliminate the need for multiple screening and confirmatory tests. This would speed up reporting and help avoid unnecessary antibiotic use."

In the United States, an estimated 500,000 people are infected annually, and more than 28,000 die from CDI. A recent national survey conducted by the Association for Professionals in Infection Control and Epidemiology suggests that 13 out of every 1,000 hospitalized patients are suffering from CDI, and more than 7,000 patients in U.S. hospitals have CDI on any given day. The average length of stay for a CDI patient is nearly three times longer than the typical patient, and CDI is estimated to lead to $1 billion in excess healthcare costs annually in the United States. CDI rates continue to increase, driven by a new epidemic strain known as BI/NAP1/027, which has now been detected in at least 38 states, Canada and 14 European countries.

"CDI poses a significant challenge for healthcare facilities around the world," said Jamie Condie, Vice President and General Manager, BD Diagnostics - Molecular Diagnostics. "The introduction of the BD GeneOhm Cdiff assay demonstrates BD's ongoing commitment to develop a broad range of products to help prevent HAIs. BD provides molecular tests for key pathogens associated with HAIs, including Staphylococcus aureus, methicillin-resistant Staphylococcus aureus, vancomycin-resistant enterococci, and now Clostridium difficile."

Cleared for the identification of toxigenic Clostridium difficile directly from stool specimens, the BD GeneOhm Cdiff assay targets the Toxin B gene, found in virtually all toxigenic Clostridium difficile strains, including the emerging BI/NAP1/027 epidemic strain. It is the only CDI molecular assay that combines high sensitivity and specificity and provides definitive test results in less than two hours. This new test may facilitate earlier and more appropriate antibiotic treatment of CDI patients. It may also lead to earlier implementation of infection control interventions that help prevent the transmission of the pathogen to other patients. Until now, diagnosing CDI rapidly has proven difficult. Traditional methods, including immunoassays, lack sufficient sensitivity, while tissue culture cytotoxicity methods are difficult to perform and require several days to yield results.

About BD

BD is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents. The Company is dedicated to improving people's health throughout the world. BD is focused on improving drug delivery, enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing research, discovery and production of new drugs and vaccines. BD's capabilities are instrumental in combating many of the world's most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs approximately 28,000 people in approximately 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, the pharmaceutical industry and the general public. For more information, please visit

SOURCE BD-Becton Dickinson
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Alsius Corporation Pre-Announces Record Fourth Quarter and Full Year 2008 Revenue
2. Allen Technologies, Inc. Announces Vigo Interactive Communication and Education System Agreement with Saint John's Health Center, Santa Monica, California
3. Rubicon Genomics Announces a Licensing Agreement With Abbott to Develop and Commercialize DNA Methylation Cancer Tests
4. Oleen Pinnacle Announces Acquisition of Partners in Health Systems
5. Thermage, Inc. Announces Name Change to Solta Medical, Inc.
6. Miami Beach Real Estate Attorney Announces Specialized Legal and Realty Services for Clients Buying Bank-Owned Luxury Miami Beach Condos
7. Genomma Lab Announces Initiation of Stock Repurchase Fund
8. Kensey Nash Corporation Announces Its Second Quarter 2009 Earnings Release Date and Teleconference
9. VA Announces $22 Million for Rural Veterans
10. Hanger Orthopedic Group, Inc. Announces Six Acquisitions Totaling $8.9 Million of Annual Net Revenue
11. Medivation Announces Participation in 27th Annual J.P. Morgan Healthcare Conference
Post Your Comments:
(Date:10/13/2017)... ... October 13, 2017 , ... The American Board of Family ... next President and Chief Executive Officer, succeeding Dr. James C. Puffer upon his retirement. ... 1, 2018 until Dr. Puffer’s retirement at the end of 2018. Upon assuming the ...
(Date:10/13/2017)... Nevada (PRWEB) , ... October 13, 2017 , ... ... Hemp CBD Oil utilizing Purzorb™ technology. Applying the Purzorb™process to full spectrum CBD oil ... required and providing a CBD form that can be easily incorporated into liquid products, ...
(Date:10/13/2017)... QUEENS, N.Y (PRWEB) , ... October 13, 2017 , ... ... recently became a member of ElderCounsel, a national organization of elder law and special ... constantly changing laws and rules. It also provides a forum to network with elder ...
(Date:10/13/2017)... ... 2017 , ... Many families have long-term insurance that covers care for a ... waiver for care if the client has a cognitive impairment diagnosis. , “What ... is often waived, so the benefits from their insurance start immediately,” said Mechell Vieira, ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Ellevate Network, the ... business to advocate for action towards gender equality at their inaugural Summit in New ... the globe, and reached a social audience of over 3 million. To watch the ...
Breaking Medicine News(10 mins):
(Date:10/12/2017)...   Divoti USA will engrave and process ... of the latest FDA requirements, which stipulates new criteria regarding medical ... need of Medical ID jewelry such as Medical ID Bracelets, can ... in terms of the new FDA requirements . ... Divoti offers this dark mark fiber laser ...
(Date:10/11/2017)... IRVING, Texas , Oct. 11, 2017  Caris ... science focused on fulfilling the promise of precision medicine, ... Institute has joined Caris, Precision Oncology Alliance™ (POA) as ... leading cancer centers, the St. Jude Crosson Cancer Institute ... to advance the use of tumor profiling, making cancer ...
(Date:10/10/2017)... 10, 2017  NDS received FDA 510(k) clearance in May 2017 ... display stand specifically designed for endoscopy environments. An innovative secondary monitor ... clinical solution to support the improvement of patient outcomes, procedural efficiency, ... ... ...
Breaking Medicine Technology: