NEW YORK (GenomeWeb News) – AdvanDx has received US Food and Drug Administration clearance for its E. coli/P. aeruginosa PNA FISH assay to identify Escherichia coli and/or
Pseudomonas aeruginosa directly from positive blood cultures.
Woburn, Mass.-based AdvanDx said that the dual-pathogen assay is the first ever test for identifying E. coli and P. aeruginosa directly from positive blood cultures. The test, which is based on AdvanDx's peptide nucleic acid probe technology, can provide rapid species identification in hours rather than days and enable therapy guiding results for 95 percent to 99 percent of patients with positive blood cultures.
According to AdvanDx, studies have shown that a 24-hour head start on appropriate therapy for Gram-negative bloodstream infections may improve clinical outcomes, reduce antibiotic resistance rates and reduce the incidences of adverse events.