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AdvanDx Receives FDA Clearance for MRSA Assay

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. 

The qualitative fluorescence in situ hybridization assay uses peptide nucleic acid probes to bind and detect mRNA sequences corresponding to the mecA gene, which often confers drug resistance in S. aureus. A positive result indicates that the cells tested contain a functioning mecA gene. 

"The test will guide caregivers to the best course of antibiotic treatment" helping clinicians to quickly determine if an infection is resistant to commonly used, well-tolerated drugs, Geoffrey McKinley, senior vice president of R&D and business development for AdvanDx, said. 

Woburn, Mass.-based AdvanDx filed for premarket notification clearance of mecA XpressFISH with the FDA in March 2014.