AdvanDx Receives FDA 510(k) Clearance for Yeast Traffic Light PN... ( New Product Provides First Capabil...)

AdvanDx Receives FDA 510(k) Clearance for Yeast Traffic Light PNA FISH(TM)

Date:9/23/2008

New Product Provides First Capability To Rapidly Identify Five Candida

Species Directly From Positive Blood Cultures In One Test

WOBURN, Mass., Sept. 23 /PRNewswire/ -- AdvanDx today announced it received FDA 510(k) clearance of the Yeast Traffic Light PNA FISH(TM) to identify Candida yeast species directly from positive blood cultures. The 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. For the first time, laboratories can identify, in a single Yeast Traffic Light test, up to five Candida species directly from positive blood cultures including C. albicans and/or C. parapsilosis, C. tropicalis, and C. glabrata and/or C. krusei in hours instead of days, enabling clinicians to provide early, effective and appropriate antifungal therapy for patients afflicted with candidemia.

Studies show that Candida species display varying resistance to commonly used antifungal agents. While C. albicans and C. parapsilosis are generally susceptible to the antifungal drug fluconazole, C. tropicalis may display intermediate resistance to the drug while C. glabrata and C. krusei display the highest level of fluconazole resistance.(2) At the same time, recent reports indicate that caspofungin, a newer and more expensive broad-spectrum antifungal drug, may be less potent against C. parapsilosis.(3) Yeast Tr
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