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US FDA Grants 510 (k) Clearance To AdvanDx’s E. coli/P. aeruginosa PNA FISH Test

AdvanDx announced that it has received US FDA 510(k) clearance for E. coli/P. aeruginosa PNA FISH to identify Escherichia coli and/or Pseudomonas aeruginosa directly from positive blood cultures. E. coli/P. aeruginosa PNA FISH is the first-ever test for identifying E. coli and P. aeruginosa directly from positive blood cultures and the latest addition to AdvanDx’s easy-to-use, molecular-based PNA FISH diagnostics platform. PNA FISH tests provide rapid species identification for the vast majority of Gram-stain results in hours instead of days, enabling therapy guiding results for 95-99% of patients with positive blood cultures. Studies show that providing a 24 hour “head start” on appropriate narrow-spectrum therapy for Gramnegative bloodstream infections may improve clinical outcomes, reduce antibiotic resistance rates and reduce the incidences of adverse events. E. coli/P. aeruginosa PNA FISH will, for the first time, enable microbiology labs to provide clinicians rapid, accurate Gram-negative pathogen identification in hours, not days. “We are very excited to launch E. coli/P. aeruginosa PNA FISH as another critical tool to help laboratories and clinicians provide faster results and improve care for patients with life threatening infections,” said Thais T. Johansen, President and CEO of AdvanDx. “Our PNA FISH diagnostic platform now provides a complete solution by enabling rapid identification results for 95 to 99% of all patients with positive blood cultures,” Johansen concluded.