AdvanDx Receives FDA 510(k) Clearance for GNR Traffic Light™ PNA FISH®
AdvanDx has received FDA 510(k) clearance for its GNR Traffic Light™ PNA FISH® test. GNR Traffic Light PNA FISH is the first test capable of simultaneously identifying Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa directly from positive blood cultures containing Gram-negative rods in less than 90 minutes.
The test is the latest addition to AdvanDx's easy-to-use, molecular-based PNA FISH diagnostics platform designed to provide rapid, therapy-guiding results that enable clinicians to provide early, effective therapy for patients with Gram-negative bloodstream infections (BSI).
GNR Traffic Light PNA FISH will enable microbiology labs to identify and report E. coli, K. pneumoniae and P. aeruginosa from positive blood cultures 1 to 2 days earlier than traditional methods.
Source: AdvanDx View latest company information
Posted: January 18, 2011
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