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AdvanDx Receives FDA 510(k) Clearance for GNR Traffic Light™ PNA FISH®

AdvanDx announced that it has received FDA 510(k) clearance for its GNR Traffic Light™ PNA FISH® test. GNR Traffic Light PNA FISH is the first test capable of simultaneously identifying Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa directly from positive blood cultures containing Gram-negative rods 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). Every year, close to 875,000 patients in the United States contract bloodstream infections, leading to over 150,000 deaths and $12 billion in patient care costs. The infection is detected when a culture of the patient's blood (i.e. a blood culture) turns positive with bacteria or yeast. Rapid and accurate identification of the specific infecting pathogen is crucial to ensure early and appropriate therapy and save patient lives.

Gram-negative BSIs are considered some of the most serious hospital-acquired infections and afflict more than 100,000 patients annually in the US. The majority of these infections, approximately 70 to 80%, are caused by E. coli, K. pneumoniae and P. aeruginosa. Increasing resistance to a multitude of antibiotic agents, especially in P. aeruginosa and increasingly in K. pneumoniae, along with slow conventional laboratory testing methods that take 2 to 3 days to identify the causative pathogen, complicate therapy decisions for clinicians. As a result, up to one third of patients afflicted by Gram-negative BSIs initially receive inappropriate antibiotic therapy which in turn leads to higher mortality rates of up to 40%, longer hospital stays and significant extra costs.

GNR Traffic Light PNA FISH will enable microbiology labs to identify and report E. coli, K. pneumoniae and P. aeruginosa 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 which studies show may improve clinical outcomes, reduce incidence of adverse events and shorten hospital length of stay.

PNA FISH is an easy-to-use and highly sensitive and specific fluorescence in situ hybridization (FISH) assay that uses PNA (peptide nucleic acid) probes to target species specific ribosomal RNA (rRNA) in live bacteria and yeast. The unique properties of the non-charged, peptide backbone of PNA probes enable the use of FISH assays in exceedingly complex sample matrixes, such as blood and blood cultures, and this in turn facilitates the development of very simple, yet very accurate tests that don't require the extensive sample preparation necessary for other nucleic acid technologies.

PNA FISH tests enable microbiology labs to provide rapid and accurate identification of bloodstream pathogens directly from positive blood cultures in hours instead of days. Clinical studies show that rapid identification of bloodstream pathogens using PNA FISH tests leads to more appropriate patient therapy that saves lives and reduces unnecessary antibiotic use, patient length of stay and hospital costs.

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