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GEN News Highlights : Jan 17, 2011

FDA Clears AdvanDx’ 90-Minute Triple Gram-Negative Bug FISH Assay

AdvanDx claims the assay will expedite diagnosing which bacterium is responsible for bloodstream infections.

AdvanDx confirmed FDA 510(k) approval for its GNR Traffic Light™ PNA (peptide nucleic acid) FISH® assay. The test has been developed to identify and simultaneously distinguish between E. coli, Klebsiella pneumonia, and Pseudomonas aeruginosa infection directly from blood cultures that are positive for Gram-negative rods in under 90 minutes. The test has already received clearance in the EU.

Designed for use on AdvanDx’ molecular PNA FISH diagnostic platform, the multicolor GNR Traffic Light PNA FISH assay can provide results 1–2 days sooner than conventional methods to help clinicians decide on the most effective therapy for patients with Gram-negative bloodstream infections, the firm claims.

AdvanDx suggests about 70–80% of the Gram-negative bloodstream infections are caused by one of the three organisms identified by its new test, yet conventional laboratory testing methods can take 2–3 days to identify the causative pathogen, significantly delaying optimum treatment decisions.

The firm’s PNA FISH platform has been developed as a highly sensitive and specific in vitro diagnostic FISH assay that uses PNA probes to target species-specific ribosomal RNA in live bacteria and yeast. A number of assays are already available in the U.S. for organisms including Staphylococcus aureus and other Staphylococcal infections, Enterococcus species, and Candida yeast infectons.