BD Announces FDA 510(k) Clearance of Simplified Test for Detection of Methicillin-Resistant Staphylococcus Aureus (MRSA)
January 10 2005 - 8:01AM
PR Newswire (US)
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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