FDA Clears Faster Versions of AdvanDx Bloodstream Pathogen Tests | GenomeWeb

NEW YORK (GenomeWeb News) – Molecular diagnostics firm AdvanDx said today that it has received 510(k) clearance from the US Food and Drug Administration for faster versions of its Escherichia coli/Pseudomonas aeruginosa and EK/P. aeruginosa diagnostic tests.

The new versions of the tests, which use peptide nucleic acid fluorescence in situ hybridization, or PNA FISH, provide results in 90 minutes instead of 2.5 hours for conventional tests because PNA probe hybridization is reduced from 90 minutes to 30 minutes, AdvanDx said.

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