BD GeneOhm(TM) Cdiff Assay Submitted for FDA Clearance
SAN DIEGO, July 7 /PRNewswire-FirstCall/ -- BD Diagnostics, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), announced today the CE marking of the BD GeneOhm(TM) Cdiff molecular assay for the rapid diagnosis of patients with Clostridium difficile infection (CDI). It is the first CDI diagnostic test that offers sensitivity, simplicity and speed in one test procedure. BD has also submitted this assay to the U.S. Food and Drug Administration for clearance.
CE marked under the European In Vitro Diagnostics Directive for the identification of toxigenic Clostridium difficile directly from stool specimens, the BD GeneOhm Cdiff assay targets the toxin B gene, found in toxigenic Clostriduim difficile strains. It is the only CDI diagnostic test that combines high assay sensitivity with a rapid turnaround time of less than two hours, facilitating earlier appropriate treatment of patients suffering from CDI and earlier implementation of infection control interventions to prevent transmission of Clostridium difficile to other patients. Until now, rapid diagnosis of CDI has been difficult since traditional methods consist of immunoassays, which lack sufficient sensitivity, and traditional "gold standard" tissue culture cytotoxicity methods, which are difficult to perform and require several days to yield results.
"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, Clarian Pathology Laboratory. "This test should improve patient care because it effectively eliminates the need for multiple screening and confirmatory assays, speeds up reporting and helps avoid unnecessary antibiotic use."
"CDI poses a significant challenge for healthcare facilities around the world," said Jamie Condie, Vice President and General Manager, BD Diagnostics - GeneOhm. "The introduction of the BD GeneOhm Cdiff assay demonstrates BD's ongoing commitment to develop a broad range of products that can help prevent healthcare-associated infections (HAIs). BD provides molecular tests for key pathogens associated with HAIs, including methicillin-resistant Staphylococcus aureus (MRSA), methicillin-susceptible Staphylococcus aureus, vancomycin-resistant Enterococci, and now Clostridium difficile."
In the United Kingdom, Clostridium difficile infections have risen 40 percent in the last three years, infecting eight times as many patients as MRSA and killing twice as many. In the United States annually, an estimated 500,000 people are hospitalized and more than 28,000 die from CDI. The average length of stay for a CDI patient is nearly three times longer than the average patient and excess healthcare costs exceed $1 billion. U.S. rates of CDI continue to increase, driven by a hypervirulent strain known as BI/NAP1/027. This dangerous strain has now been isolated in at least 38 states, Canada and 14 European countries.
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 http://www.bd.com.
This press release contains certain estimates and other forward-looking statements (as defined under Federal securities laws) regarding BD's performance, including future performance, products or other events or developments that BD expects to occur or anticipates occurring in the future. All such statements are based upon current expectations of BD and involve a number of business risks and uncertainties. Actual results could vary materially from anticipated results described, implied or projected in any forward-looking statement. Factors that could cause actual results to vary materially from any forward-looking statement include, but are not limited to: competitive factors; pricing and market share pressures; difficulties inherent in product development and delays in product introductions; changes in regional, national or foreign economic conditions; increases in energy costs and their effect on, among other things, the cost of producing BD's products; fluctuations in costs and availability of raw materials and in BD's ability to maintain favorable supplier arrangements and relationships; changes in healthcare or other governmental regulation; as well as other factors discussed in this press release and in BD's filings with the Securities and Exchange Commission. We do not intend to update any forward-looking statements to reflect events or circumstances after the date hereof except as required by applicable laws or regulations.
|SOURCE BD-Becton Dickinson|
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