Medical Center Saves $130K in Antifungal Drug Costs with C. albicans PNA FISH(TM), a Rapid Diagnostic Test

WOBURN, Mass., Sept. 19 /PRNewswire/ -- A study published by the University of Maryland Medical Center (UMMC) in the September 2006 issue of Journal of Clinical Microbiology (http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abs tractPlus&list_uids=16954279&query_hl=1&itool=pubmed_docsumhttp://jcm.asm.org/ cgi/content/abstract/44/9/3381http:/jcm.asm.org/cgi/content/abstract/44/9/3381 ) describes saving $130,231 in antifungal therapy costs by using PNA FISH for same day identification and reporting of Candida albicans from positive blood cultures.(1)

Authors of the study are Drs. Graeme Forrest, Richard Venezia, Kristine Mankes, Mary Ann Jabra-Rizk, Elizabeth Weekes, Jennifer (Kristie) Johnson and Durry Lincalis.

  In summary, the authors found that:
  - The implementation of C. albicans PNA FISH resulted in antifungal
    therapy savings of $1,808 per candidemia patient for 72 patients (total

of $130,231) and similar to those reported earlier by Alexander et al(2) http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abst ractPlus&list_uids=16466898&query_hl=1&itool=pubmed_docsum

  - The time to identification of C. albicans reduced to same day with PNA
    FISH from an average of 44 hours (range, 36 to 92 hours) by conventional
    methods
  - For 72 patient samples tested, C. albicans PNA FISH was 100% sensitive
    and specific and confirmed that conventional microbiology methods mis-
    identified 6 C. dubliniensis as C. albicans

Dr. Graeme Forrest, Infectious Diseases Physician and Director of Antibiotic Utilization at UMMC, said, "The ability of our lab to provide rapid and accurate results allows us to make the most appropriate antifungal therapy decisions for our patients."

"Incorporating PNA FISH testing into our routine workflow, not only for Candida species but also for Staphylococcus and Enterococcus species, and rapidly reporting results to our physicians and pharmacists, allows us to play an even more critical role in antimicrobial decision making," commented Dr. Richard Venezia, Director of Clinical Microbiology at UMMC.

According to the study, "the most pronounced effect of the PNA FISH test was on caspofungin usage in patients with candidemia due to C. albicans. In this group, there was a significant reduction in the DDD/patient usage of caspofungin (P < 0.05), with a corresponding decrease in antifungal costs ..."

"A test positive for C. albicans ensured the preferred use of fluconazole; however, the antifungal choice for a negative test would depend on the patient's clinical condition (hemodynamic instability or endocarditis), host factors (AIDS or neutropenia), and prior history of Candida colonization and antifungal therapy or prophylaxis."

The authors conclude, "In our experience, the financial savings in reducing caspofungin usage surpassed the cost of the PNA FISH test and has led to the development of straightforward hospital specific treatment algorithms. We have since increased the frequency of PNA FISH to twice daily to further decrease the reporting time."(1)

About Candidemia

Candidemia is an infection of the bloodstream that is initially diagnosed when a blood culture turns positive with Candida species. http://www.doctorfungus.org/mycoses/human/candida/Candidemia.htm

Candidemia is one of the most important hospital-acquired infections and the 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 increasing resistance to antifungal agents in such species 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 C. albicans PNA FISH(TM)

C. albicans PNA FISH (http://www.advandx.com/default.asp?id=2460) is a qualitative nucleic acid hybridization assay intended for identification of Candida albicans from blood cultures and is available for in vitro diagnostic use (IVD). 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) of C. albicans. Results are visualized using fluorescence microscopy. Fluorescing cells indicates C. albicans 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 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. Forrest et al. J. Clin. Microbiol. 2006 44: 3381-3383 http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abst ractPlus&list_uids=16954279&query_hl=1&itool=pubmed_docsumhttp://jcm.asm.org/c gi/content/abstract/44/9/3381http:/jcm.asm.org/cgi/content/abstract/44/9/3381

2. Alexander et al. Diagn Microbiol Infect Dis. April 2006;54(4):277-82.

Epub 2006 Feb 8 http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abst ractPlus&list_uids=16466898&query_hl=4&itool=pubmed_docsum

3. Fridkin, S. K. Clin Infect Dis. 2005 Nov 15;41(10):1455-60. Epub 2005

Oct 13. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abst ractPlus&list_uids=16231257&query_hl=6&itool=pubmed_docsum