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BD MAX™ MRSA XT Assay with eXTended Detection Technology Receives FDA ClearanceJan 13, 2014
FRANKLIN LAKES, N.J., January 13, 2014 – BD Diagnostics, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, announced today it has received FDA clearance to market the BD MAX™ MRSA XT Assay for use on the fully-automated BD MAX™ System. This is the second assay from BD Diagnostics capable of detecting newly emerging MRSA strains with the novel mecC gene. Launched in 2013, the BD MAX™ StaphSR Assay reports results for both Staphylococus aureus (SA) and methicillin-resistant Staphylococus aureus (MRSA) and was the first commercially available assay in the U.S. to detect mecC strains of MRSA. Both assays use eXTended Detection Technology to identify a broad range of SA strains including mecA and mecC dropout mutants and new strains of MRSA that may not be detected by other assays.
“Assay design is critical to detect MRSA accurately and ensure appropriate infection control interventions are applied,” said Dr. Patrick Murray, Worldwide Director of Scientific Affairs, BD Diagnostics – Diagnostic Systems. “The BD MAX MRSA XT Assay helps improve patient safety by providing hospitals with a new solution to detect the latest strains of this drug-resistant superbug.”
Molecular assays for MRSA are used in active surveillance programs to identify colonized patients rapidly. Active surveillance is a proven strategy to reduce transmission in healthcare settings and helps prevent infection in vulnerable patients.i Inaccurate detection may contribute to uncontrolled transmission of MRSA and inappropriate use of healthcare resources.With many commercial assays, SA strains carrying SCCmec where the mecA gene is absent (commonly called “dropout mutants”) may be incorrectly classified as MRSA. These false positive results can lead to unnecessary and expensive isolation and treatment of patients.ii MRSA strains with the newly emerging mecC gene account for nearly three percent of all new MRSA casesiii in some communities but cannot be detected by all assays.iv These false negative results can lead to uncontrolled transmission of undetected strains of MRSA.v
As a pioneer in healthcare-associated infections (HAIs), BD has the insights and expertise to provide hospitals innovative solutions that can improve patient care. The BD MAX MRSA XT Assay is the latest milestone demonstrating BD’s commitment to providing advanced assays to detect and prevent HAIs. Other HAI assays available on the BD MAX System include BD MAX™ Cdiff for the detection of toxigenic Clostridium difficile DNA, and BD MAX StaphSR. BD MAX™ HAI Solutions combine efficiency through system automation with the flexibility to perform multiple HAI assays in the same run, allowing hospital laboratories to customize testing in response to current and future challenges in the fight against HAIs.
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of healthcare by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for healthcare providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to healthcare. In 2017, BD welcomed C. R. Bard and its products into the BD family. For more information on BD, please visit bd.com
For more information on BD, please visit bd.com.
i Jain et al., N Engl J Med 2011;364:1419-30. Veterans Affairs Initiative to Prevent Methicillin-Resistant Staphylococcus aureus Infections
ii Blanc et al., JCM 2011;49:722-724. High Proportion of Wrongly Identified Methicillin-Resistant Staphylococcus aureus Carriers by Use of a Rapid Commercial PCR Assay Due to Presence of Staphylococcal Cassette Chromosome Element Lacking the mecA Gene.
iii Petersen et al., Epidemiology of methicillin-resistant Staphylococcus aureus carrying the novel mecC gene in Denmark corroborates a zoonotic reservoir with transmission to humans Clin Micro Infect 2013;19:E16-E22
iv Shore et al., Antimicrobial Agents and Chemotherapy. 2011;55:3765-3773
v Worby et al., Am J Epidemiology advanced access published online April 16, 2013. Estimating the Effectiveness of Isolation and Decolonization Measures in Reducing Transmission of Methicillin-resistant Staphylococcus aureus in Hospital General Wards