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BD MAX™ StaphSR Assay with eXTended Detection Technology Receives CE Mark
Baltimore, MD (September 2, 2013) – BD Diagnostics, a segment of BD (Becton, Dickinson and Company), announced today the availability of the CE-marked BD MAX™ StaphSR assay with eXTended Detection Technology in Europe for use on the fully-automated BD MAX™ System. The assay with eXTended detection accurately identifies Staphylococcus aureus and methicillin-resistant Staphylococcus aureus (MRSA) from nasal swabs in surgical patients at risk for colonization. This is the only commercially-available molecular assay that detects both the MREJ target that is found only in MRSA and drug-resistance genes: mecA and the recently discovered mecC cassette.i
Surgical site infections (SSIs) are the most common healthcare-associated infection in surgical patients.ii These infections are associated with increased length of hospitalization of seven to ten days with attributable costs as high as $29,000 per episode.iii Patients who develop an SSI have a two-to-eleven fold higher risk of death, compared with surgical patients without an SSI.iv Nasal carriage of S. aureus is a well-defined risk factor for subsequent infection in surgical patients. Rapid screening and targeted decolonization decreases SSIs and improves clinical and economic outcomes for surgical patients.v,vi
"The rapidly expanding menu on the fully-automated BD MAX™ System provides hospital laboratories a flexible, efficient and cost-effective solution for accurate molecular testing," said Tom Polen, President, BD Diagnostics – Diagnostic Systems. "The BD MAX™ StaphSR assay can be performed in the same run as MRSA, Clostridium difficile and other assays, enabling laboratories the flexibility to consolidate molecular testing on a single platform to improve overall efficiencies and costs."
With results available in about two hours compared to two days with culture methods, the BD MAX™ StaphSR assay provides accurate and timely detection of colonized patients. Assays that do not detect mecC strains are prone to false-negative results.vii The BD MAX™ StaphSR assay also includes mecA to ensure accurate detection of "dropout" strains that have lost that gene and can remain undetected by other methods.
The BD MAX™ System is the first and only fully-automated, bench-top molecular system designed to perform a broad range of molecular tests. The growing menu of assays includes BD MAX™ MRSA for the detection of MRSA and BD MAX™ Cdiff for the detection of toxigenic Clostridium difficile. Introduction of the BD MAX™ StaphSR assay into the European market represents BD’s commitment to rapidly expand its menu, offering laboratories a broad range of molecular tests that meet both their current and future clinical needs.
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 nearly 30,000 associates in more than 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 www.bd.com.
i Laurent et al., Emerging Infectious Disease 2012;18:1465-1467
ii Mangram et al.,. Infect Control Hosp Epidemiol. 1999;20:247-280
iii Anderson et al., Infect Control Hosp Epidemiol 2008; 29:S51–S61
iv Anderson et al., Infect Control Hosp Epidemiol 2008; 29:S51–S61
v Bode et al., N Engl J Med 2010;362:9-17
vi Van Rijen et al., PLoS ONE 2012;7(8): e43065
vii Garcia-Alvarez et al., Lancet Infect Dis. 2011;11:595-603