AdvanDx announces European launch of CE-IVD marked GNR Traffic Light PNA FISH test

AdvanDx today announced the launch of its CE-IVD marked GNR Traffic Light™ PNA FISH® test in Europe.  GNR Traffic Light PNA FISH is the first-ever test capable of simultaneously identifying Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa directly from positive blood cultures in less than 90 minutes.  The GNR Traffic Light is the latest addition to AdvanDx's easy-to-use, molecular-based PNA FISH diagnostics platform designed to provide rapid, therapy-guiding results enabling clinicians to provide early, effective therapy for patients with Gram-negative bloodstream infections.

Every year, an estimated 100,000 patients develop bloodstream infections (BSI) due to Gram-negative pathogens, mainly E. coli, K. pneumoniae and P. aeruginosa.  Patients afflicted by these serious infections spend an average of 15 days in the hospital, suffer mortality rates as high as 40% and cost institutions between $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 and increasingly in K. pneumoniae, creating complex therapy decisions for clinicians.  Treatment challenges are further compounded by conventional laboratory testing methods that take 24-48 hours or longer to identify the causative pathogen, forcing clinicians to treat patients empirically. This empirical antibiotic coverage can lead to both unnecessary treatment with broad-spectrum antibiotics as well as inadequate treatment if highly virulent and resistant pathogens are not suspected and covered for.

Studies show that providing a 24 hours "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.  GNR Traffic Light PNA FISH will enable microbiology labs to provide clinicians rapid, accurate Gram-negative pathogen identification results in hours, instead of days.

"The GNR Traffic Light PNA FISH test demonstrates AdvanDx's commitment to developing cutting-edge molecular diagnostic products that provide fast results for these serious infections," said Thais T. Johansen, President and CEO of AdvanDx. "This latest PNA FISH test provides another tool to help laboratories and clinicians improve antibiotic selection, care and outcomes for critically ill patients with bloodstream infections," Johansen concluded.