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Yeast Traffic Light™ PNA FISH™ Candida Detection Submitted to FDA

The Yeast Traffic Light PNA FISH™ for detection of Candida yeast species from positive blood cultures has been submitted by AdvanDx for FDA 510(k) clearance.

Yeast Traffic Light™ is the latest addition to AdvanDx's easy-to-use, molecular-based PNA FISH™ 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™ 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]

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.

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Posted on June 4, 2008