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AdvanDx Receives FDA 510(k) Clearance for 90 Minutes PNA FISH(R) Protocol for Identifying Staphylococcal Bloodstream Pathogens
Date:12/10/2009

proved therapy decisions and outcomes for patients with bloodstream infections by providing results in hours, instead of days to help physicians and pharmacists optimize antibiotic therapy earlier. A clinical study performed at the Washington Hospital Center (Washington, D.C.) demonstrated that rapid identification and notification of PNA FISH results reduced ICU and overall mortality rates by 82% and 53% respectively, while reducing antibiotic use for patients with CNS positive blood cultures. In a separate study performed at the University of Maryland Medical Center (Baltimore, MD) rapid PNA FISH results, helped reduce unnecessary vancomycin use by 4.5 doses, length of stay by 2 days and hospital costs by $4,005 for patients with CNS contaminated blood cultures.(1,3)

With the introduction of the 90 minutes PNA FISH protocol, laboratories will be able to further improve turn-around times for critical results and thereby help clinicians further improve antibiotic selection, care, and outcomes for patients with staphylococcal bloodstream infections.

"We are extremely pleased with the latest FDA clearances for the faster PNA FISH protocols for S. aureus and Coagulase-Negative Staph," said Thais T. Johansen, President and CEO of AdvanDx. "Staphylococci present significant challenges for managing patient care and controlling hospital costs. With fast PNA FISH results, hospitals have a tool to help both improve patient care and reduce unnecessary costs," Johansen concluded.

About AdvanDx

AdvanDx is the leading provider of advanced molecular diagnostic products for the diagnosis and treatment of life-threatening, bloodstream infections. AdvanDx's easy-to-use products provide fast and accurate results that enable dramatic improvements in patient care and help to save lives and reduce hospital costs.

AdvanDx's products employ standard laboratory techniques and equipment to reduce startup, implementati
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SOURCE AdvanDx
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