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news.AdvanDx, a provider of advanced molecular diagnostic products, has received FDA 510k clearance for EK/P aeruginosa PNA FISH to identify Escherichia coli and/or Klebsiella pneumoniae as well as Pseudomonas aeruginosa directly from positive blood cultures.
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According to AdvanDx, the EK/P aeruginosa PNA FISH is the first-ever test capable of identifying E coli and/or K pneumoniae 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 now provide rapid, therapy-guiding results for 95-99% of patients with bloodstream infections and positive blood cultures. These tests enable microbiology labs to provide rapid and accurate identification of bloodstream pathogens directly from positive blood cultures in hours instead of days, the company said.
Thais Johansen, president and CEO of AdvanDx, said: “We are very excited to launch EK/P aeruginosa PNA FISH and provide another critical tool to help laboratories and clinicians provide faster results and improve care for patients with these life threatening infections.
“Our PNA FISH diagnostic platform now provides a complete solution by enabling rapid identification results for 95 to 99% of all patients with bloodstream infections.”