AdvanDx Receives FDA Clearance for MRSA Assay | GenomeWeb

NEW YORK (GenomeWeb) – Molecular diagnostics firm AdvanDx announced today that it has received 510(k) clearance from the US Food and Drug Administration for its mecA XpressFISH assay for the rapid detection of methicillin-resistant and methicillin-susceptible Staphylococcus aureus. 

The test provides results directly from blood culture samples in about an hour, the firm said, compared to 48 to 72 hours for conventional laboratory detection methods. 

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