AdvanDx Launches the First LNA-Based In Vitro Diagnostic Test for Detection of Antibiotic Resistant "Superbugs".WOBURN, Mass. -- AdvanDx, Inc. today announced the launch of vanA/B EVIGENE in Europe, the first LNA-based in vitro diagnostic test for detecting the antibiotic resistant "Superbugs superbugs, n.pl infectious diseases that are unresponsive to known antibiotic treatments. " Vancomycin-Resistant Enterococci (VRE) and Vancomycin-Resistant Staphylococcus aureus vancomycin-resistant Staphylococcus aureus VRSA Infectious disease A long anticipated bacterium first identified in a clinical specimen in mid-2002; the isolate was susceptible to chloramphenicol, linezolid, quinupristin-dalfopristin, T-S. (VRSA VRSA Vancomycin-resistant Staphylococcus aureus. Cf Vancomycin-resistant enterococcus. ) 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 A locked nucleic acid (LNA), often referred to as inaccessible RNA, is a modified RNA nucleotide. The ribose moiety of an LNA nucleotide is modified with an extra bridge connecting the 2' and 4' carbons. (LNA) probes with EVIGENE, a signal amplified sandwich hybridization hybridization /hy·brid·iza·tion/ (hi?brid-i-za´shun) 1. crossbreeding; the act or process of producing hybrids. 2. molecular hybridization 3. 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 Centers for Disease Control and Prevention (CDC), agency of the U.S. Public Health Service since 1973, with headquarters in Atlanta; it was established in 1946 as the Communicable Disease Center. in the May 2007 issue of the Journal of Clinical Microbiology The Journal of Clinical Microbiology is an academic journal published by the American Society for Microbiology. The title is commonly abbreviated JCM and the ISSN is 0095-1137 for the print version, and 1098-660X for the electronic version. 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 Small interfering RNA (siRNA), sometimes known as short interfering RNA or silencing RNA, are a class of 20-25 nucleotide-long double-stranded RNA molecules that play a variety of roles in biology. (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 Cedars-Sinai Medical Center is a world-renowned hospital located in Los Angeles, California. History Cedars-Sinai is the result of a merger in 1961 between two major Los Angeles hospitals, Cedars of Lebanon and Mount Sinai Home for the Incurables, with Steve Broidy as , the Johns Hopkins Hospital
For more information, please visit www.AdvanDx.com or contact: 1 Fosheim et al. J Clin Microbiol. 2007 May;45(5):1611-3. |
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