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FDA clearance

The PCR-based assays run on the company's Aries system, which itself received FDA clearance in October 2015.

The M1, a lower-throughput version of the company's Aries System, can process up to six samples and six assays at a time.

Roche's test becomes the second PCR-based MRSA test approved for clinical use in the US, joining Cepheid's Xpert MRSA/SA nasal assay for the GeneXpert PCR platform.

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