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Medical Devices / Submissions and Approvals

Hologic’s MRSA Assay Receives CE Mark in Europe

July 6, 2018

Hologic’s Panther Fusion MRSA assay received CE Mark approval in Europe, expanding the Panther Fusion system’s menu of assays.

The MRSA assay detects and differentiates between Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA by analyzing nasal samples.

The assay is capable of identifying empty cassette variants and a broad range of strains, including the Bengal Bay clone.

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