AdvanDx announces it has received 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 molecular-based PNA FISH diagnostics platform. PNA FISH tests now 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.
Every year, an estimated 100,000 patients develop bloodstream infections (BSI) due to Gram-negative pathogens such as E. coli and/or P. aeruginosa. Patients afflicted by these serious infections spend an average of 5-24 days in the hospital, suffer mortality rates as high as 40% and cost institutions on average $40,000 to $60,000 per case.
These grim statistics are due in part to Gram-negative bacteria’s increasing resistance to a multitude of antibiotic agents, especially in P. aeruginosa, creating complex therapy decisions for clinicians. Treatment challenges are further compounded by conventional laboratory testing methods for Gram-negative pathogens that take 24-48 hours to provide results, forcing clinicians to treat patients empirically, which may not provide full coverage for the infecting pathogen.
Studies show that providing a 24 hour "head start" on appropriate narrow-spectrum therapy for Gram-negative bloodstream infections may improve clinical outcomes, reduce antibiotic resistance rates and reduce the incidences of adverse events. The test will, for the first time, enable microbiology labs to provide clinicians rapid, accurate Gram-negative pathogen identification in hours, not days.