AdvanDx Launches First LNA-Based In Vitro Diagnostic Test For Detection Of Antibiotic Resistant "Superbugs"

Main Category: MRSA / Drug Resistance
Also Included In: Infectious Diseases / Bacteria / Viruses;  Pharma Industry / Biotech Industry
Article Date: 20 Sep 2007 - 20:00 PDT

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AdvanDx, Inc. announced the launch of 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.

vanA/B EVIGENE combines the high specificity of Locked Nucleic Acid (LNA) probes with EVIGENE, a signal amplified sandwich hybridization 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)." [1]

"We are extremely 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 Dr. Henrik Stender, Vice President for Research and Development, at AdvanDx. Dr. Stender continued, "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."

About LNA

Locked Nucleci Acid (LNA) 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.

Regulatory status of vanA/B EVIGENE

EU: For in vitro diagnostic use.
US: For research use only. Not for use in diagnostic procedures.

About AdvanDx, Inc.

AdvanDx is the world's leading provider of fast, accurate and easy-to-use in vitro molecular diagnostic products that rapidly identify infectious pathogens to enable dramatic improvements in patient outcomes while reducing hospital costs.

Every year, 350,000 patients contract bloodstream infections, causing over 90,000 unnecessary deaths and significant costs to the U.S. healthcare system. The rapid identification of the infecting pathogens is crucial to ensure early and appropriate therapy to save lives and cut costs. In response, AdvanDx leverages its molecular diagnostic products to detect and identify infectious pathogens and provide therapy-directing results in hours versus days.

AdvanDx's products are easy-to-use, requiring only standard lab equipment, thus reducing startup, implementation, technician and maintenance time, while providing fast results without sacrificing accuracy. Customers include: the Cleveland Clinic, Cedars-Sinai Medical Center, the Johns Hopkins Hospital, the University of Maryland Medical Center and Detroit Medical Center. AdvanDx has formed partnerships with bioMérieux and others to provide its products and services to hospitals worldwide.

[1] Fosheim et al. J Clin Microbiol. 2007 May;45(5):1611-3.

http://www.advandx.com