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    BD Announces CE Marking Of Rapid Molecular Test To Identify Superbug From Nasal And Wound Specimens
    By Anna Ohlden | December 20th 2007 02:30 AM | Print | E-mail | Track Comments

    SAN DIEGO, California, December 20 /PRNewswire/ --

    - First Molecular Test to Simultaneously Identify Staphylococcus aureus and Methicillin-Resistant Staphylococcus aureus from Nasal and Wound Specimens

    BD Diagnostics, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), announced today the European launch of the BD GeneOhm(TM) StaphSR assay for nasal and wound specimens as a CE marked product under the European In Vitro Diagnostics Directive. This is the first assay for the rapid and simultaneous identification and differentiation of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) directly from nasal and wound specimens. It was CE marked for positive blood cultures earlier in the year. This assay helps physicians rapidly administer the right antimicrobial treatment for patients with wounds infected with SA or MRSA. It will also allow patients colonized with SA or MRSA to be decolonized and receive appropriate prophylactic antibiotics prior to surgery.

    "Preoperative screening for nasal carriage of Staphylococus aureus and subsequent treatment of carriers with mupirocin nasal ointment is associated with significant reduction in the postoperative Staphylococcus aureus infection rate by more than 50 percent," said Jan Kluytmans, MD, Consultant Microbiologist, Amphia Hospital Breda/Oosterhout, and Professor of Medical Microbiology and Infection Control, VUmc, Amsterdam.

    "Healthcare workers around the world are diligently attempting to control transmission and infection caused by multidrug-resistant organisms, such as MRSA," said Vince Forlenza, Executive Vice President, BD. "CE marking for all three specimen claims for the BD GeneOhm StaphSR assay reflects BD's commitment to providing high-quality diagnostic tests in the battle against staphylococcal infections."

    A recent study reported in the Journal of American Medical Association estimates that 94,360 patients acquire an invasive MRSA infection each year, leading to an estimated 18,650 deaths in the United States. MRSA has become the most common cause of skin and soft tissue infections (SSTIs), often presenting as a "spider bite," but has also been associated with sepsis and necrotizing pneumonia.

    Recent studies have shown a dramatic increase in patients suffering from SSTIs, with SA found to be the causative pathogen in 76 percent of cases. Of these SA isolates, 78 percent were MRSA. Although the vast majority of patients with MRSA SSTIs in the studies received empirical antimicrobial therapy, more than half of the time the prescribed agent was not active against MRSA.

    The BD GeneOhm StaphSR assay is currently pending FDA clearance for various specimen types. BD is also developing rapid molecular tests for the detection of two other organisms that cause severe healthcare-associated infections. These tests will identify the vanA and vanB genes associated with vancomycin-resistant enterococci and the toxin gene associated with Clostridium difficile.

    About BD

    BD, a leading global medical technology company that manufactures and sells medical devices, instrument systems and reagents, is dedicated to improving people's health throughout the world. BD is focused on improving drug therapy, enhancing the quality and speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines. The Company'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, industry and the general public. For more information, please visit 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.

    Web site: http://www.bd.com

    Barbara Kalavik of BD Public Relations, +1-201-847-4209, barbara_kalavik@bd.com