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AdvanDx's Traffic Light blood culture test cleared by FDA

This article was originally published in Clinica

Executive Summary

The US FDA has granted 510(k) clearance for AdvanDx's GNR Traffic Light PNA FISH test. It is the first assay to simultaneously detect Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa directly from positive blood cultures containing Gram-negative rods (GNRs) in less than 90 minutes, the Woburn, Massachusetts firm claims. The rapid fluorescence in situ hybridisation (FISH) test uses fluorescently labelled peptide nucleic acid (PNA) probes that target ribosomal RNA from these bacterial species. Around 70-80% of Gram-negative bloodstream infections are caused by these three species. Identifying the cause of infection can help physicians prescribe the most appropriate antimicrobial treatment, as some bacteria, particularly P aeruginosa, are increasingly developing resistance.

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