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AdvanDx Receives FDA 510(k) Clearance for 90 Minutes PNA FISH(R) Protocol for Identifying Enterococcal Bloodstream Pathogens.

Publication: PR Newswire
Publication Date: 27-OCT-09
Format: Online
Delivery: Immediate Online Access

Article Excerpt
Pathogen Identification Results in 90 Minutes Direct from Positive Blood Cultures Faster Results to Help Clinicians Improve Antibiotic Selection and Outcomes for Critical Infections First of 8 PNA FISH Tests to Transition to Faster, 90 Minutes Protocol

WOBURN, Mass. and VEDBAEK, Denmark, Oct. 27 /PRNewswire/ -- AdvanDx today announced that it has received FDA 510(k) clearance for a fast, 90 minutes protocol for its E. faecalis/OE PNA FISHA' test. 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...

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