AdvanDx gets FDA clearance for E Coli diagnostic test

AdvanDx, a provider of advanced molecular diagnostic products, has received the FDA 510(k) clearance for E coli/P aeruginosa PNA FISH to identify Escherichia coli or Pseudomonas aeruginosa directly from positive blood cultures.

According to the company, the 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 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, the company said.

E coli or 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, the company added.

Thais Johansen, president and CEO of AdvanDx, said: 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. 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.