VanA/B Evigene is the first Locked nucleci acid (LNA)-based in vitro diagnostic test for vancomycin-resistant enterococci (VRE) and vancomycin-resistant staphylococcus aureus (VRSA)
AdvanDx has launched the VanA/B Evigene in Europe, said to be 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 oranisms 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.
VanA/B Evigene combines the high specificity of locked nucleic acid (LNA) probes with Evigene, a signal amplified sandwich hybridisation assay platform, to rapidly and accurately detect both the VanA and VanB genes that confer vancomycin resistance in enterococci and staphylococcus aureus.
A study published by the Centers for Disease Control and Prevention in the May 2007 issue of the Journal of Clinical Microbiology concluded that the Evigene technology "...demonstrated 100% sensitivity and specificity for the detection of vanA in S aureus (VRSA) and VanA or VanB in enterococci (VRE)".
"We are excited to see AdvanDx introduce the first LNA-based in vitro diagnostic test.
"This marks the transition of LNA from a research tool to a clinical diagnostic tool," said Henrik Stender, vice president for research and development, at AdvanDx.
"VanA/B Evigene compliments our other Evigene and PNA Fish products for rapid identification of antibiotic resistant and virulent bacteria that help clinicians improve therapy for patients with these terrible infections.
"We look forward to leveraging our technology portfolio along with new partnerships, to develop and market rapid, accurate and therapy guiding diagnostic products within infectious diseases as well as within other critical diseases." Locked nucleci acid (LNA) probes are conformationally restricted nucleic acid analogues 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.
AdvanDx says VanA/B Evigene is approved for in vitro diagnostic use in the EU, but in the USA is for research use only and not for use in diagnostic procedures.