AdvanDx Submits Yeast Traffic Light PNA FISH(TM) For FDA 510(k) Clearance For Detection Of Candida Species In Positive Blood Cultures

Main Category: Infectious Diseases / Bacteria / Viruses
Also Included In: Blood / Hematology;  Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 04 Jun 2008 - 2:00 PDT

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AdvanDx announced the FDA 510(k) submission of Yeast Traffic Light PNA FISH(TM) for detection of Candida yeast species from positive blood cultures. Yeast Traffic Light(TM) is the latest addition to AdvanDx's easy-to-use, molecular-based PNA FISH(TM) diagnostics platform that provides rapid identification of bloodstream pathogens in hours instead of days. Candidemia, a bloodstream infection caused by Candida species is one of the most serious hospital acquired infections, afflicting over 24,000 patients in the U.S. every year. Immunocompromised transplantation, oncology and AIDS patients are especially at risk for contracting the infection with mortality rates as high as 50%.(1) While identification of the infecting Candida species is used to guide effective antifungal therapy, conventional laboratory methods can take up to 5 days or longer. Yeast Traffic Light(TM) will for the first time enable laboratories to rapidly detect, in a single test, up to five Candida species directly from positive blood cultures including C. albicans and C. parapsilosis, C. tropialis, and C. glabrata and C. krusei in hours instead of days. The rapid results should enable clinicians to provide early, effective and appropriate antifungal therapy for patients with candidemia.

A recent study by Della-Latta et al. presented at the 2008 ECCMID meeting in Barcelona, Spain demonstrated that rapid identification of Candida species using PNA FISH can significantly impact antifungal selection and care for patients with Candidemia. In the study, rapid identification of C. albicans led to a switch to the antifungal drug fluconazole for 70% of the patients that had been on caspofungin, a newer, more broad-spectrum but more expensive antifungal drug. At the same time, rapid identification of C. glabrata, a Candida species with high levels of resistance to fluconazole, led to an 81% switch to caspofungin for those patients that had otherwise been given fluconazole. Based on the study results, the authors concluded that the PNA FISH test "can impact the appropriate selection of the most effective antifungal therapy, thereby making it a clinically relevant diagnostic assay." (2)

"The Yeast Traffic Light PNA FISH test demonstrates AdvanDx's commitment to developing cutting-edge molecular diagnostic products that provide fast results for these serious infections," said Thais T. Johansen, President and CEO of AdvanDx. "The test will ultimately enable clinicians to provide more appropriate care, improve antifungal selection and hopefully improve outcomes for their patients," Johansen concluded.

About Bloodstream Infections

Every year, 350,000 patients contract bloodstream infections, causing over 90,000 unnecessary deaths and significant costs to the healthcare system. The infection is detected when a culture of the patient's blood, i.e. a blood culture, turns positive with bacteria and yeast. Rapid and accurate identification of the specific infecting pathogen is crucial to ensure early and appropriate therapy and save patient lives.

About PNA FISH(TM)

PNA FISH is an easy-to-use and highly sensitive and specific fluorescence in situ hybridization (FISH) assay that uses PNA (peptide nucleic acid) probes to target species specific ribosomal RNA (rRNA) in bacteria and yeast. PNA FISH tests enable microbiology labs to provide rapid and accurate identification of bloodstream pathogens directly from positive blood cultures in hours instead of days. Clinical studies show that rapid identification of bloodstream pathogens using PNA FISH tests leads to more appropriate patient therapy that saves lives and reduces unnecessary antibiotic use, patient length of stay and hospital costs.

About AdvanDx

AdvanDx is the world's leading provider of advanced molecular diagnostic products for the prevention, diagnosis and treatment of life-threatening, bacterial infections. AdvanDx's easy-to-use products provide fast and accurate results that enable dramatic improvements in patient care and help to save lives and reduce hospital costs.

AdvanDx's products employ standard laboratory techniques and equipment to reduce startup, implementation, technician and maintenance time, while providing fast results without sacrificing accuracy. Major medical centers, reference labs, government institutions and community hospitals throughout the United States, Europe and Asia rely on AdvanDx products as integral parts of their medical care.

References:

1. Spellberg et al. Current Treatment Strategies for Disseminated Candidiasis. Clin. Infec. Dis. 42: 244-251. 2005

2. Della-Latta et al. Impact of Rapid Identification of C. albicans and C. glabrata Directly from Blood Cultures using PNA FISH Technology on Selection of Antifungal Therapy. Poster 1382. ECCMID 2008. Barcelona, Spain.

AdvanDx
http://www.AdvanDx.com