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AdvanDx Receives FDA 510(k) Clearance for E. coli/P. aeruginosa PNA FISH(R)
Date:1/30/2009

First Diagnostic Test for Identifying E. coli and P. aeruginosa Directly from Positive Blood Cultures

PNA FISH to Provide Critical Results 24-48 Hours Sooner Than Conventional Methods Helping Clinicians to Improve Care and Outcomes for 100,000 Patients with Bloodstream Infections

WOBURN, Mass. and VEDBAEK, Denmark, Jan. 30 /PRNewswire/ -- AdvanDx today 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 develop bloodstream infections (BSI) due to Gram-negative pathogens such as E. coli and/or P. aeruginosa. Patients afflicted by these serious infections spend an average of 5-24 days in the hospital, suffer mortality rates as high as 40% and cost institutions on average $40,000 to $60,000 per case (1,2). These grim statistics are due in part to Gram-negative bacteria's increasing resistance to a multitude of antibiotic agents, especially in P. aeruginosa, creating complex therapy decisions for clinicians. Treatment challenges are further compounded by conventional laboratory testing methods for Gram-negative pathogens that take 24-48 hours to provide results, forcing clinicians to treat patients empirically which may not provide full coverage for the infecting pathogen.

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