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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

WOBURN, Mass., and VEDBAEK, Denmark, Dec. 10 /PRNewswire/ -- AdvanDx today announced that it has received FDA 510(k) clearance for a fast, 90 minutes protocol for its S. aureus PNA FISH® and S. aureus/CNS 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 excellent 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.

Staphylococcus species are both the most frequent causes of bloodstream infections (BSI) and blood culture contamination. True infections caused by Staphylococcus aureus present considerable clinical challenges associated with increased mortality rates, prolonged hospital stays and add significant extra hospital costs.(1) In the United States alone, 300,000 hospitalized patients contract a S. aureus infection leading to more than 12,000 deaths, 2.7 million excess LOS days and close to $9.5 billion in excess hospital charges.(2) Blood culture contamination with Coagulase-Negative Staphylococci (CNS) on the other hand, account for up to 30% of all positive blood cultures and often result in a false diagnosis of a true staphylococcal bloodstream infection that leads to unnecessary coverage with broad-spectrum antibiotics, extra length of stay and unnecessary extra costs. As conventional identification methods can take several days to differentiate between true infection and contamination, clinicians must rely on empiric therapy which may result in either unnecessary or inadequate treatment.

Since 2003, the use of PNA FISH for rapid identification of staphylococcal bloodstream pathogens has drastically im
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