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AdvanDx Receives FDA 510(k) Clearance for 90 Minutes Protocol for Yeast Traffic Light® PNA FISH®
Date:7/29/2010

ncluding C. albicans and/or C. parapsilosis, C. tropicalis, and C. glabrata and/or C. krusei. 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 echinocandins may be less potent against C. parapsilosis (3).  As a result, Yeast Traffic Light PNA FISH was designed to provide identification of critical Candida species in hours instead of days, enabling clinicians to optimize antifungal drug selection much earlier for patients with candidemia.

A study performed by Della-Latta et al. at Columbia University Medical Center demonstrated that rapid PNA FISH results led to an early switch to caspofungin, an echinocandin, for 81% of patients with C. glabrata patients treated empirically with fluconazole.  The rapid results also led to an early switch to fluconazole for 70% of patients with C. albicans infections treated empirically with caspofungin.  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."(4) With the introduction of the 90 minutes PNA FISH protocol, laboratories will now be able to further improve turn-around times for critical results and thereby help clinicians further improve care for patients with candidemia.

"The FDA clearance for Yeast Traffic Light PNA FISH completes our ambitious initiative to transition all PNA FISH tests to the shor
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1. AdvanDx Submits Yeast Traffic Light PNA FISH(TM) for FDA 510(k) Clearance for Detection of Candida species in Positive Blood Cultures
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3. AdvanDx Launches Fast, 90 Minutes Protocol for All CE-IVD Marked PNA FISH(R) Tests in Europe
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