New Assay Detects Rapidly Emerging Strains of Antibiotic-Resistant Enterobacteriaceae

A molecular assay for detecting the three major antibiotic resistance genes acquired by strains of the pathogenic carbapenem-resistant Enterobacteriaceae (CRE) is now being made available as a research tool and as part of an effort to gather feedback on its potential clinical diagnostic performance.

Becton, Dickinson and Company (BD; Franklin Lakes, NJ, USA) has now released a research use only (RUO) molecular test designed to rapidly detect antibiotic resistance genes in highly pathogenic CRE resistant to nearly all available antibiotics; in some cases there are no treatments effective against CRE infections. The assay is performed on the automated BD MAX System and produces results in just two hours, compared to several days for conventional culture methods.

BD is making the assay available for RUO to a limited number of infectious disease experts and researchers. “We are offering this assay initially as a research tool to help BD and infectious disease researchers explore its clinical utility while we pursue development of an in vitro diagnostic solution,” said Patrick Murray, PhD, Worldwide Director of Scientific Affairs, BD Diagnostics - Diagnostic Systems.

Global incidence of CRE infections has increased dramatically over the past decade. CRE, “now routinely cause both community- and hospital-acquired infections. The medical community urgently needs more rapid and accurate [CRE detection] methods,” said Dr. Brian Currie, vice president and Medical Director for Research at Montefiore Medical Center and Assistant Dean for Clinical Research at the Albert Einstein College of Medicine. The most concerning are CRE that have acquired carbapenemase genes including KPC, NDM, and OXA-48. The BD MAX assay is the first automated assay to detect all three of these genes directly from specimens.

The BD MAX System is the first and only automated, bench-top system designed to perform a broad range of molecular tests. This includes in vitro diagnostic (IVD) assays, as well as user-defined protocols and life science research applications. More than 15 state-of-the-art assays are currently under development. Assays already available for clinical IVD use on the BD MAX System include methicillin-resistant Staphylococcus aureus (MRSA) and toxigenic Clostridium difficile, both CE-marked for IVD use in Europe. The MRSA assay was FDA-cleared with CLIA Moderate Complexity categorization earlier this year. The toxigenic C. difficile assay has been submitted to the FDA for 510(k) review and clearance.

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