AdvanDx receives clearance from the US Food and Drug Administration (FDA) for 90 minutes PNA FISH Protocol for identifying Gram-negative bloodstream pathogens.
AdvanDx has announced that it has received FDA 510(k) clearance for a fast, 90 minutes protocol for its E.coli/P. aeruginosa PNA FISH and EK/P. aeruginosa PNA FISH tests. The faster protocol reduces the PNA FISH turn-around time from the original 2.5 hours to 90 minutes and thereby help clinicians further improve pseudomonal vs. non-pseudomonal antibiotic selection for patients with Gram-negative bloodstream infections.
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