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AdvanDx
AdvanDx Receives FDA 510k Clearance for E. coli/P. aeruginosa PNA FISH
February 13th, 2009
AdvanDx announced it received FDA 510(k) clearance for E. coli/P. aeruginosa PNA FISH(R) to identify Escherichia coli and/or Pseudomonas aeruginosa directly from positive blood cultures. E. coli/P. aeruginosa PNA FISH is the first-ever test for identifying E. coli and P. aeruginosa directly from positive blood cultures and the latest addition to AdvanDx's easy-to-use, molecular-based PNA FISH diagnostics platform. PNA FISH tests now provide rapid species identification for the vast majority of Gram-stain results in hours instead of days, enabling therapy guiding results for 95-99% of patients with positive blood cultures. Every year, an estimated 100,000 patients...
Source: Health Business Week (2009-02-13)
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