BD Announces CE Marking of the BD GeneOhm™ VanR Molecular Test for the Rapid Detection of Vancomycin Resistance

Molecular Technology Aids Hospitals in the Prevention of Vancomycin-Resistant Enterococci (VRE) Transmission and Infection

BD Diagnostics, a segment of BD (Becton, Dickinson and Company), announced today the CE marking of the BD GeneOhm™ VanR assay for the rapid detection of vanA and vanB genes, which are associated with vancomycin-resistant Enterococci (VRE). BD will immediately begin commercializing this important new assay throughout Europe.

The BD GeneOhm VanR assay is a qualitative in vitro polymerase chain reaction (PCR) test for the detection of vancomycin-resistant genes directly from perianal and rectal swabs. As the first CE-marked molecular assay to directly test clinical specimens, the test allows hospitals and reference laboratories to identify patients colonized with the resistant organisms associated with VRE in as little as two hours. In contrast, conventional culture-based microbiology algorithms require three to four days to produce definitive test results. The new test will help enable earlier implementation of infection control measures to prevent VRE transmission and infection, leading to decreased length of stay and reduced healthcare costs.

“With the addition of the BD GeneOhm VanR assay, BD continues to demonstrate its commitment to improving patient care and preventing healthcare-associated infections (HAIs). Our existing HAIs-related molecular menu includes assays for the rapid detection of methicillin-resistant and methicillin-susceptible Staphylococcus aureus,” commented Jamie Condie, Vice President/General Manager, BD Diagnostics – GeneOhm.

VRE-associated infections have a high attributable mortality rate and are associated with excess costs and length of stay. VRE prevalence in healthcare facilities has increased steadily since it was first reported in 1987 and now accounts for approximately 30 percent of enterococcal infections in intensive care unit patients in the United States. In Europe, the majority of countries report vancomycin-resistance rates ranging from 25 to 50 percent of enterococcal isolates. This alarming increase in endemic rates of VRE is prompting healthcare institutions to take preventative action.

In addition to the patient impact of HAIs caused by multidrug-resistant organisms, substantial financial savings can be realized by preventing these infections. The attributable cost of a VRE bacteremia has been estimated to be $27,000 per case. A study in the Journal of Clinical Microbiology demonstrated that the use of PCR-based active surveillance testing for VRE colonization resulted in decreased length of stay for patients discharged to long-term care facilities by almost two days, saving the hospital an estimated $205,000 annually.