EU gives CE mark approval of Xpert MRSA NxG for detecting MRSA infections- Cepheid

Cepheid announced commercial availability, outside the United States, of Xpert MRSA NxG, a next generation version of the market-leading molecular diagnostic test for Methicillin-Resistant Staphyloccus aureus (MRSA) as the assay has achieved CE-IVD status under the European Directive on In Vitro Diagnostic Medical Devices.

Xpert MRSA NxG is an update to the menu of 23 tests available internationally to run on Cepheid's GeneXpert System, a molecular diagnostic platform. GeneXpert Systems run proprietary Xpert test cartridges. The Xpert test menu spans healthcare-associated infections, sexual health, critical infectious disease, and oncology, and offers 23 tests outside the US, and 20 tests in the US.