AdvanDx fluorescence in situ hybridization test earns FDA clearance

AdvanDx (Woburn, MA) has received FDA 510(k) clearance for its GNR Traffic Light PNA FISH test. This fluorescence in situ hybridization (FISH) test simultaneously identifies E. coli, K. pneumoniae and P. aeruginosa directly from positive blood cultures containing gram-negative rods in less than 90 minutes.

GNR Traffic Light PNA FISH will enable microbiology labs to identify and report E. coli, K. pneumoniae and P. aeruginosa from positive blood cultures one to two days earlier than traditional methods, according to the company. The rapid results will provide clinicians a “head start” on selecting appropriate and effective therapy for patients with gram-negative bloodstream infections (BSIs), which studies show may improve clinical outcomes, reduce incidence of adverse events and shorten hospital length of stay.

Source: AdvanDx

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Posted by Lee Mather

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