AdvanDx Receives FDA 510(k) Clearance for EK/P. aeruginosa P... ( First Diagnostic Test for Identifying...)

AdvanDx Receives FDA 510(k) Clearance for EK/P. aeruginosa PNA FISH(R)

Date:5/5/2009

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

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

WOBURN, Mass., and VEDBAEK, Denmark, May 5 /PRNewswire/ -- AdvanDx today announced it received FDA 510(k) clearance for EK/P. aeruginosa PNA FISH(R) to identify Escherichia coli and/or K. pneumoniae as well as Pseudomonas aeruginosa directly from positive blood cultures. EK/P. aeruginosa PNA FISH is the first-ever test capable of identifying E. coli and/or K. pneumoniae 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, therapy-guiding results for 95-99% of patients with bloodstream infections and positive blood cultures.

Every year, an estimated 100,000 patients develop bloodstream infections (BSI) due to Gram-negative pathogens mainly E. coli, K. pneumoniae and 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 and increasingly in K. pneumoniae, creating complex therapy decisions for clinicians. Treatment challenges are further compounded by conventional laboratory testing methods that take 24-48 hours or longer to identify the causative pathogen forcing clinicians to treat patients empirically. This empirical antibiotic coverage can lead to both unnecessary treatment wit
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