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AdvanDx
AdvanDx Submits Yeast Traffic Light PNA FISH for FDA 510k Clearance for Detection of Candida species in Positive Blood Cultures
June 20th, 2008
AdvanDx announced the FDA 510(k) submission of Yeast Traffic Light PNA FISH(TM) for detection of Candida yeast species from positive blood cultures. 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...
Source: Health Business Week (2008-06-20)
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