BD Announces FDA 510(k) Clearance of Simplified Test for Detection of Methicillin-Resistant Staphylococcus Aureus (MRSA) BALTIMORE, Jan. 10 /PRNewswire-FirstCall/ -- BD (Becton, Dickinson and Company), through its BD Diagnostics segment, today announced that the U.S. Food and Drug Administration has cleared the BBL(TM) CHROMagar(TM) MRSA product. This new prepared plated medium simplifies the process, decreases the time to result and offers high sensitivity and specificity for methicillin-resistant Staphylococcus aureus (MRSA) identification. BBL CHROMagar MRSA allows microbiology laboratories to identify patients colonized with MRSA more quickly and easily than the time-consuming and labor- intensive processes currently available. BBL CHROMagar MRSA allows for the direct detection and identification of most MRSA within 24 hours. The cost benefits associated with reducing nosocomial infections can be significant. "This technology will be extremely useful to those who wish to identify patients colonized with MRSA," said Dr. Bill Jarvis of Emory University School of Medicine and President, Jason and Jarvis Associates. "Since MRSA colonization leads to infection in a specific patient and is a risk factor for transmission of MRSA to other patients, rapid identification of those with MRSA colonization will reduce the risk of infection in colonized patients, by enabling their clinicians to intervene, and reduce the risk of patient-to- patient transmission by permitting isolation of those who are MRSA-colonized. Furthermore, this technology will markedly increase the rate at which community-associated or hospital-acquired MRSA patients are identified. Thus, more rapid isolation and treatment can occur. The multiple benefits of this rapid identification method will improve patient treatment, reduce the risk of transmission in healthcare settings, and reduce the burden of MRSA in U.S. hospitals." About MRSA The prevalence of nosocomial infections caused by MRSA has been increasing for several years in many countries around the world.(1) The U.S. Centers for Disease Control and Prevention estimates that between 60,000 and 80,000 Americans die each year from nosocomial infections and the cause in the majority of cases is S. aureus. About BBL CHROMagar MRSA BBL CHROMagar MRSA utilizes a new chromogenic technology which permits the detection of MRSA using chromogenic substrates and a cephalosporin. MRSA strains will grow in the presence of antibiotics and produce mauve-colored colonies resulting from hydrolysis of the chromogenic substrates. In clinical evaluations, BBL CHROMagar MRSA displayed 8% greater recovery(2) of MRSA than traditional screening algorithm and has the capability to identify MRSA earlier than most traditional algorithms. This unique technology requires less technologist time and improves the workflow in the laboratory. BBL CHROMagar MRSA allows for the direct detection and identification of most MRSA within 24 hours, or at 48 hours with a confirmatory test. About BD BD is a medical technology company that serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public. BD manufactures and sells a broad range of medical supplies, devices, laboratory equipment and diagnostic products. For the fiscal year ended September 30, 2004, BD reported total revenues of $4.935 billion. (1) Reacher, M.H. et al. 2000 Bacteremia and antibiotic resistance of its pathogens reported in England and Wales between 1990 and 1998:trend analysis. Br. Med. J. 320:213-6. (2) BBL CHROMagar package insert. DATASOURCE: BD (Becton, Dickinson and Company) CONTACT: Barbara Kalavik of BD Public Relations, +1-201-847-4209, Web site: http://www.bd.com/

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