AdvanDx, Inc. Releases Data From IDSA Abstract: Impact Of Peptide Nucleic Acid (PNA) Fluorescence In Situ Hybridization (FISH) For Enterococcal Blood Stream Infections

WOBURN, Mass., Oct. 5 /PRNewswire/ -- AdvanDx, Inc. announces the availability of data on the impact of PNA FISH(TM) for Enterococcal blood stream infections (BSIs). The data are part of an oral abstract presentation (131) that is part of the program made available ahead of the Infectious Diseases Society of America (IDSA) 2006 Annual Meeting. The abstract authors can only comment after the abstract is presented on Friday, October 13 at 10:30AM in Toronto, Canada.

Authors of the abstract are: Latoya Toombs, Pharm.D.(1), Elizabeth Weekes, Pharm.D.(1), Graeme Forrest, MBBS(2), Durry Licalis, PT(3), Jennifer K. Johnson, Ph.D.(3), and Richard A. Venezia, Ph.D.(3)

In the study, E. faecalis PNA FISH was initiated at the University of Maryland Medical Center on January 1st, 2006 for identification of E. faecalis and other enterococci in positive blood cultures with Gram-positive cocci in chains (GPCH). The study included data on demographics, days from GPCH to final culture and sensitivities, initial and final antibiotic therapy, days to change therapy, and patient outcomes at end of stay. Enterococcal BSI from 2005 were used as historical controls.

The following results are included in the abstract to be presented at the IDSA 2006 Annual Meeting: "PNA FISH was performed on 101 GPCH. It accurately identified all 27 E. faecalis, 36 E. faecium and 38 Non-enterococci (streptococci). All E. faecalis were ampicillin sensitive and FISH allowed for earlier conversion to ampicillin from linezolid or vancomycin from 2.5 to at 1.7 days (p=0.06). With E. faecium, 80% of isolates were vancomycin-resistant enterococci (VRE). Initial empiric antibiotic therapy was inaccurate in 61% of the retrospective and 67% of PNA FISH groups respectively. However PNA FISH was able to significantly reduce the days to change to appropriate therapy (linezolid) from 2.5 to 1.4 days (p=0.003) and there was a trend towards less mortality (36% vs. 14%) (p=0.06). Importantly, 8 deaths occurred before empiric antibiotic therapy could be changed in the controls compared to 0 deaths with PNA FISH."

The authors conclude, "PNA FISH for Enterococcus sp. is rapid and accurate with trends towards an earlier switch to ampicillin with E. faecalis BSI. Its greatest impact was with E. faecium BSI where it significantly reduced the time to correct antimicrobial therapy and reduced mortality."

Dr. Henrik Stender, Vice President for Research and Development at AdvanDx said, "By reducing mortality using PNA FISH, the authors of the study have demonstrated the ultimate power of rapid diagnostics. In fact, E. faecalis PNA FISH may offer the first significant improvement in VRE bloodstream infection therapy since the approval of quinupristin-dalfopristin and linezolid in 1999 and 2000."

About E. faecalis PNA FISH(TM)

E. faecalis PNA FISH(TM) is a qualitative nucleic acid hybridization assay intended for identification of Enterococcus faecalis and other enterococci from blood cultures and is available for in vitro diagnostic (IVD) use. The 2.5 hours fluorescence in situ hybridization (FISH) assay uses dual color fluorescence-labeled peptide nucleic acid (PNA) probes that target the species-specific ribosomal RNA (rRNA) in E. faecalis and other enterococci. Results are visualized using fluorescence microscopy. Green fluorescing cells indicates E. faecalis while red fluorescing cells indicate other enterococci, including Enterococcus faecium. No fluorescence indicates another species is present in the positive blood culture.

About AdvanDx

AdvanDx, Inc. develops and markets in vitro diagnostic kits based on its PNA FISH(TM) and EVIGENE(TM) technologies to aid the diagnosis and prevention of infectious diseases. The PNA FISH and EVIGENE product lines provide rapid identification results for bacteria and yeast to support appropriate antibiotic therapy and overall patient care. PNA FISH is available for in vitro diagnostic use (IVD) in both the United States and Europe while EVIGENE is available for research use only (RUO) in the United States and for in vitro diagnostic use in Europe. Headquartered on the 128 technology highway around Boston, AdvanDx has established R&D facilities both in the United States and Denmark with sales and marketing capabilities located throughout the United States and Europe. For more information, please visit http://www.AdvanDx.com or call +1-781-376-0009.

(1) University of Maryland Medical Center Department of Pharmacy, Baltimore, MD, (2) University of Maryland School of Medicine, Baltimore, MD, (3) University of Maryland Department of Pathology, Baltimore, MD. For more information, contact: Henrik Stender AdvanDx +1-781-376-0009 henrik.stender@advandx.com

AdvanDx, Inc.

CONTACT: Henrik Stender of AdvanDx, +1-781-376-0009,henrik.stender@advandx.com

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