AdvanDx Inc, Woburn, Mass, launched its vanA/B Evigene in Europe, the first LNA-based in vitro diagnostic test for detecting the antibiotic resistant superbugs vancomycin-resistant Enterococci (VRE) and vancomycin-resistant Staphylococcus aureus (VRSA) in positive blood cultures and clinical isolates.
Infections with antibiotic resistant superbugs, such as VRE and VRSA, are serious problems for patients and hospitals worldwide. Rapid and accurate identification of these pathogens is crucial to ensuring early, appropriate and effective therapy that will allow hospitals to reduce mortality, patient length of stay and overall costs while in the long run tackling the problem of antibiotic resistance.
The test combines the high specificity of locked nucleic acid (LNA) probes with Evigene, a signal amplified sandwich hybridization assay platform, to detect both the vanA and vanB genes that confer vancomycin resistance in Enterococci and Staphylococcus aureus.
Locked nucleci acid probes are conformationally restricted nucleic acid analogs that provide enhanced affinity and discrimination as compared to DNA probes. The high sensitivity and specificity of LNA probes allow for accurate detection of low abundance nucleic acids, such as bacterial and viral DNA, microRNA (miRNA), messenger RNA (mRNA), and small interfering RNA (siRNA). Detection of these genetic materials can provide important diagnostic and therapeutic information within the areas of infectious diseases and oncology, as well as drug resistance and therapy monitoring.
“This marks the transition of LNA from a research tool to a clinical diagnostic tool,” said Henrik Stender, PhD, VP for research and development, at AdvanDx.
Although vanA/B Evigene has been approved for in vitro diagnostic use in Europe, to date, it has been approved only for research in the United States.
AdvanDx customers include the Cleveland Clinic, Cedars-Sinai Medical Center, the Johns Hopkins Hospital, the University of Maryland Medical Center and Detroit Medical Center. The company has formed partnerships with bioMérieux and others.