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AdvanDx Receives FDA 510(k) Clearance for Yeast Traffic Light PNA FISH(TM)
Date:9/23/2008

affic Light was designed to identify these Candida species as early as possible and provide rapid and actionable results to help clinicians guide appropriate antifungal therapy.

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 fluconazole for 70% of the patients that had been on caspofungin. 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."(4)

"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 AdvanDx

AdvanDx is the world's leading provider of advanced molecular diagnostic prod
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