FDA Clears Roche’s PCR-Based MRSA Nasal Test

Jul 15, 2010

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The US Food and Drug Administration has cleared Roche Molecular System's LightCycler MRSA Advanced Test for detecting methicillin-resistant Staphylococcus aureus for clinical use in the US, Roche said this week.

Roche's test becomes the third PCR-based MRSA test approved for clinical use in the US, joining Cepheid's Xpert MRSA/SA nasal assay for its GeneXpert PCR platform; and Becton Dickinson's GeneOhm MRSA assay, which runs on Cepheid's SmartCycler platform.

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