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

Tuesday, September 23, 2008 General News
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WOBURN, Mass., Sept. 23 AdvanDx today announced itreceived FDA 510(k) clearance of the Yeast Traffic Light PNA FISH(TM) toidentify Candida yeast species directly from positive blood cultures. TheYeast Traffic Light(TM) is the latest addition to AdvanDx's easy-to-use,molecular-based PNA FISH(TM) diagnostics platform that provides rapididentification of bloodstream pathogens in hours instead of days.

Candidemia, a bloodstream infection caused by Candida species is one ofthe most serious hospital acquired infections, afflicting over 24,000 patientsin the U.S. every year. Immunocompromised transplantation, oncology and AIDSpatients are especially at risk for contracting the infection with mortalityrates as high as 50%.(1) While identification of the infecting Candidaspecies is used to guide effective antifungal therapy, conventional laboratorymethods can take up to 5 days or longer. For the first time, laboratories canidentify, in a single Yeast Traffic Light test, up to five Candida speciesdirectly from positive blood cultures including C. albicans and/or C.parapsilosis, C. tropicalis, and C. glabrata and/or C. krusei in hours insteadof days, enabling clinicians to provide early, effective and appropriateantifungal therapy for patients afflicted with candidemia.

Studies show that Candida species display varying resistance to commonlyused antifungal agents. While C. albicans and C. parapsilosis are generallysusceptible to the antifungal drug fluconazole, C. tropicalis may displayintermediate resistance to the drug while C. glabrata and C. krusei displaythe highest level of fluconazole resistance.(2) At the same time, recentreports indicate that caspofungin, a newer and more expensive broad-spectrumantifungal drug, may be less potent against C. parapsilosis.(3) Yeast TrafficLight was designed to identify these Candida species as early as possible andprovide rapid and actionable results to help clinicians guide appropriateantifungal therapy.

A recent study by Della-Latta et al. presented at the 2008 ECCMID meetingin Barcelona, Spain demonstrated that rapid identification of Candida speciesusing PNA FISH can significantly impact antifungal selection and care forpatients with candidemia. In the study, rapid identification of C. albicansled to a switch to fluconazole for 70% of the patients that had been oncaspofungin. At the same time, rapid identification of C. glabrata, a Candidaspecies with high levels of resistance to fluconazole, led to an 81% switch tocaspofungin for those patients that had otherwise been given fluconazole.Based on the study results, the authors concluded that the PNA FISH test "canimpact 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 commitmentto developing cutting-edge molecular diagnostic products that provide fastresults for these serious infections," said Thais T. Johansen, President andCEO of AdvanDx. "The test will ultimately enable clinicians to provide moreappropriate care, improve antifungal selection and hopefully improve outcomesfor their patients," Johansen concluded.

About Bloodstream Infections

Every year, 350,000 patients contract bloodstream infections, causing over90,000 unnecessary deaths and significant costs to the healthcare system. Theinfection is detected when a culture of the patient's blood (i.e. a bloodculture) turns positive with bacteria and yeast. Rapid and accurateidentification of the specific infecting pathogen is crucial to ensure earlyand appropriate therapy and save patient lives.

About AdvanDx

AdvanDx is the world's leading provider of advanced molecular diagnosticproducts for the prevention, diagnosis and treatment of life-threatening,bacterial infections. AdvanDx's easy-to-use products provide fast


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