AdvanDx, Inc. Releases Data From IDSA Late-Breaker Abstract: Identification Of C. albicans and C. glabrata Directly From Positive Blood Culture Bottles Via A Dual Color PNA FISH(TM) Assay

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WOBURN, Mass., Oct. 13 /PRNewswire/ -- AdvanDx, Inc. announces the availability of data on identification of Candida albicans and Candida glabrata directly from positive blood culture bottles, via a dual-color PNA FISH(TM) assay. The data are part of a late-breaker abstract (LB-22) included in the program made available in advance of the Infectious Diseases Society of America (IDSA) 2006 Annual Meeting. The abstract authors may only comment after the abstract is presented on Saturday, October 14 at 12:30PM in Toronto, Canada.

Authors of the abstract are: Fann Wu, M.D., Ph.D.(1), Phyllis Della-Latta, Ph.D.(1), Rachel Addison, MT(ASCP), MPH(2), Barbara Alexander, M.D.(2), Gary Procop, M.D.(3), Deborah Wilson, MT(ASCP)(3), William Merz, M.D.(4), Michael Gherna, BS(4), Jennifer K. Johnson, Ph.D.(5), Ava Roberts, MT(ASCP)(5), Janeen R. Shepard, BS(6), and Mark J. Fiandaca, BS(6).

In the study, fluorescent-labeled PNA probes, targeting specific 26S rRNA sequences of C. albicans (CA) and C. glabrata (CG), were developed and evaluated by fluorescence in situ hybridization (PNA FISH) for identification from positive blood culture bottles.

The following results are included in the abstract to be presented at the IDSA 2006 Annual Meeting: Five clinical microbiology laboratories tested 162 yeast-positive BC (representing 14 species); Positive and negative predictive values for identification of CA were: 100% (68/68), 98.9% (93/94), 100% (29/29) and 100% (133/133) for CG.

The authors conclude, “Dual color PNA FISH is a rapid (<3 hr) and accurate method for identification of both CA and CG directly from positive BC bottles. Rapid identification of these species should lead to improvements in antifungal therapy while reducing hospital drug expenses.”

Dr. Henrik Stender, Vice President for Research and Development at AdvanDx said, “We are very excited to see such high performance data across multiple institutions for our next generation, dual-color PNA FISH for the identification of Yeast-positive blood cultures. Once available for in vitro diagnostic use, the ability of clinical labs to accurately and rapidly identify both C. albicans and C. glabrata directly from positive blood cultures in a single test, should be important for guiding optimal antifungal therapy for patients with candidemia.”

About Candidemia

Candidemia is an infection of the bloodstream that is initially diagnosed when a blood culture turns positive with Candida species. Candidemia is one of the most prevalent hospital-acquired infections and its incidence is rising, due to the increasing population of immuno-compromised patients such as transplantation, oncology and AIDS patients. The infection is associated with a high mortality rate and can be difficult to treat, due in part to its increasing resistance to antifungal agents in species such as Candida glabrata. While antifungal therapy can be based on species identification, conventional laboratory identification can take up to 5 days or more. As a result, patients are often treated empirically, with broad-spectrum agents which are known to be nephrotoxic, expensive or both.(3)

About PNA FISH(TM)

PNA FISH(TM) is a qualitative nucleic acid hybridization assay intended for identification of bacteria and yeast species from blood cultures. The 2.5 hours fluorescence in situ hybridization (FISH) assay uses fluorescence-labeled peptide nucleic acid (PNA) probes that target the species-specific ribosomal RNA (rRNA) in bacteria and yeast. Results are visualized using fluorescence microscopy. Fluorescing cells indicate the target species, while 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 in the diagnosis and prevention of infectious diseases. The PNA FISH and EVIGENE product lines provide rapid identification results for bacteria and yeast, supporting 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) Columbia University Medical Center, New York Presbyterian Hospital, New York, NY, (2) Duke University Medical Center, Durham, NC, (3) Cleveland Clinic, Cleveland, OH, (4) Johns Hopkins Medical Institutions, Baltimore, MD, (5) University of Maryland Medical Center, Baltimore, MD, (6) AdvanDx, Woburn, MA.

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