AdvanDx GNR Traffic Light PNA FISH test wins FDA clearance

AdvanDx has received US Food and Drug Administration (FDA) 510(k) clearance for its GNR Traffic Light PNA FISH test, designed to simultaneously identify Gram-negative bacteria from positive blood cultures in less than 90 minutes.

The test is the latest addition to AdvanDx’s easy-to-use, molecular-based PNA FISH diagnostics platform designed to provide rapid, therapy-guiding results that enable clinicians to provide early, effective therapy for patients with Gram-negative bloodstream infections (BSI).

The test will enable microbiology labs to identify Gram-negative rods like Escherichia (E) coli, Klebsiella (K) pneumoniae and Pseudomonas (P) aeruginosas from positive blood cultures 1 to 2 days earlier than traditional methods.

The rapid results will provide clinicians a ‘head start’ on selecting appropriate and effective therapy for patients with Gram-negative bloodstream infections.

AdvanDx president and CEO Thais Johansen said the GNR Traffic Light PNA FISH test provides another molecular diagnostic test to the PNA FISH platform, further improving AdvanDx capability to aid laboratories and clinicians in improving antibiotic selection, care and outcomes for critically ill patients with bloodstream infections.