AdvanDx Gets FDA Nod for Bloodstream Pathogen Test | GenomeWeb

NEW YORK (GenomeWeb News) – Molecular diagnostics company AdvanDx announced today that it has received clearance from the US Food and Drug Administration for a 90-minute version of its peptide nucleic acid fluorescence in situ hybridization (PNA FISH) test for the bloodstream pathogen Enterococcus faecalis.

AdvanDx secured FDA 510(k) clearance for the test, which is faster than the existing two-and-a-half hour E. faecalis PNA FISH test but appears to have similar sensitivity and specificity, based on clinical validation studies in the US and Europe.

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