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AdvanDx Receives FDA 510(k) Clearance for 90 Minutes PNA FISH(R) Protocol for Identifying Gram-Negative Bloodstream Pathogens
Date:12/22/2009

WOBURN, Mass. and VEDBAEK, Denmark, Dec. 22 /PRNewswire/ -- AdvanDx today announced that it has received FDA 510(k) clearance for a fast, 90 minutes protocol for its E. coli/P. aeruginosa PNA FISH® and EK/P. aeruginosa PNA FISH® tests. The faster protocol reduces the PNA FISH turn-around time from the original 2.5 hours to 90 minutes by reducing PNA probe hybridization from 90 minutes to 30 minutes. Clinical validation studies performed at hospitals in the United States demonstrated 100% equivalence between the 90 minutes protocol and the original PNA FISH protocol, ensuring the faster protocol maintains the very high sensitivity and specificity required versus slower, conventional methods.

"Gram-negative bloodstream infections can be very difficult to treat, especially due to the highly variable antimicrobial resistance patterns associated with different species. The ability of the PNA FISH assay to identify Pseudomonas aeruginosa in contrast to Escherichia coli and Klebsiella pneumoniae directly from a positive blood culture within 90 minutes, can lead to the initiation of pathogen-specific empiric antimicrobial regimens. This assay can have a real-time, positive impact on patient therapy and management," said Dr. Phyllis Della-Latta, Professor of Clinical Pathology in Medicine and Director of Clinical Microbiology Service at Columbia University Medical Center, New York-Presbyterian Hospital (New York, NY).

Every year, an estimated 100,000 patients develop bloodstream infections (BSI) due to Gram-negative pathogens such as Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa. Gram-negative bloodstream infections are associated with mortality rates as high as 40% and can be difficult to treat due to increasing resistance to antimicrobial agents, especially for P. aeruginosa.(1) Treatment challenges are further compounded by convent
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