AdvanDx announced the launch of its CE-IVD marked GNR Traffic Light™ PNA FISH® test in Europe. GNR Traffic Light PNA FISH is the first-ever test capable of simultaneously identifying (i)Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa directly from positive blood cultures in less than 90 minutes. Every year, close to 875,000 patients in the United States contract bloodstream infections, leading to over 150,000 deaths and $12 billion in patient care costs. The infection is detected when a culture of the patient’s blood (i.e. a blood culture) turns positive with bacteria or yeast. Rapid and accurate identification of the specific infecting pathogen is crucial to ensure early and appropriate therapy and save patient lives.
PNA FISH is an easy-to-use and highly sensitive and specific fluorescence in situ hybridization (FISH) assay that uses PNA (peptide nucleic acid) probes to target species specific ribosomal RNA (rRNA) in live bacteria and yeast. The unique properties of the non-charged, peptide backbone of PNA probes enable the use of FISH assays in exceedingly complex sample matrixes, such as blood and blood cultures, and this in turn facilitates the development of very simple, yet very accurate tests that don’t require the extensive sample preparation necessary for other nucleic acid technologies. PNA FISH tests enable microbiology labs to provide rapid and accurate identification of bloodstream pathogens directly from positive blood cultures in hours instead of days. Clinical studies show that rapid identification of bloodstream pathogens using PNA FISH tests leads to more appropriate patient therapy that saves lives and reduces unnecessary antibiotic use, patient length of stay and hospital costs.