BD Diagnostics, a segment of Becton, Dickinson and Company, has announced the release of a research use only (RUO) molecular test designed to rapidly detect antibiotic resistance genes found in the superbug known as carbapenem-resistant Enterobacteriaceae (CRE). These deadly organisms are associated with high mortality rates, are easily spread from patient to patient, and are resistant to nearly all antibiotics. Rapid identification is critical to allow proper treatment and isolation of patients.
Incidence of carbapenem-resistant organisms has increased dramatically over the past decade. The most concerning are CRE that have acquired carbapenemase genes including KPC, NDM, and OXA-48. The assay can detect all three of these genes directly from specimens. Performed on the fully-automated BD MAX System, it is designed to detect carbapenem resistance genes and produces results in just two hours. Conventional culture methods take several days to report results. BD is making the assay available, for research use only, to a limited number of infectious disease experts and researchers to gather feedback on its performance. The RUO assay is not for in vitro diagnostic (IVD) use.
Assays already available on the BD MAX System to address healthcare-associated infections include methicillin-resistant Staphylococcus aureus (MRSA) and toxigenic Clostridium difficile, both CE-marked for IVD use in Europe. The BD MAX MRSA assay was FDA-cleared with CLIA Moderate Complexity categorization earlier this year. The toxigenic Clostridium difficile assay has been submitted to the FDA for 510(k) review and clearance. Learn more about the BD MAX system.
