FDA Clears AdvanDx Test for Gram-negative Bloodstream Infection | GenomeWeb

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.

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