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FDA Clears AdvanDx Test for Gram-negative Bloodstream Infection

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – AdvanDx announced today that its GNR Traffic Light PNA FISH test has received 510(k) clearance from the US Food and Drug Administration.

The test is the first capable of simultaneously identifying Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa directly from blood cultures containing Gram-negative rods in less than 90 minutes, the molecular diagnostics firm said.

According to the company, which has offices in Woburn, Mass., and Vedbaek, Denmark, the GNR Traffic Light PNA FISH test identifies E. coli, K. pneumoniae and P. aeruginosa from positive blood cultures one to two days earlier than with traditional methods, allowing physicians to start appropriate treatment more quickly.

In a statement, the company said that Gram-negative blood stream infections are considered among the most serious hospital-acquired infections, affecting more than 100,000 patients in the US each year. Of these infections, about 70 percent to 80 percent are caused by E. coli, K. pneumoniae and P. aeruginosa and increased resistance to antibiotics and the time it takes to get test results with traditional testing methods — two to three days — make it challenging to treat the infections.

As a result, up to 33 percent of patients with Gram-negative blood stream infections initially receive inappropriate antibiotic therapy, leading to higher mortality rates of up to 40 percent, longer hospital stays, and significant extra costs, AdvanDx said.