Cepheid gets European approval of MRSA screening test

March 31, 2016 – SUNNYVALE. 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). Xpert MRSA NxG has been updated to identify mecA- and mecC- containing MRSA strains and detect new and emerging SCCmec subtypes with enhanced performance.  The assay has achieved CE-IVD status under the European Directive on In Vitro Diagnostic Medical Devices.  Xpert MRSA NxG is an important update to the menu of 23 tests available internationally to run on Cepheid’s GeneXpert® System, the world’s leading molecular diagnostic platform with over 10,000 systems deployed globally in both developed and emerging market countries.

MRSA is one of the most commonly identified antibiotic-resistant pathogens globally, with up to 53 million people worldwide estimated to carry MRSA.1  Furthermore, approximately 171,000 healthcare-associated MRSA infections are acquired annually in the European Union (EU), resulting in 5,400 attributable deaths, more than 1 million excess days of hospitalization, and €380 million in excess in-hospital costs.2

“New and emerging MRSA clones, such as livestock-associated strains, and distinct homologues of mecA resistance genes, such as mecC,3 pose a threat to efforts to contain the spread of antimicrobial resistance around the globe, which are predicated on the fast and accurate diagnosis of infections to guide patient treatment and management,” said David Persing, M.D., Ph.D., Cepheid’s Chief Medical and Technology Officer.  “Xpert MRSA NxG is the latest tool in the fight against MRSA.  Its enhanced features, such as room temperature storage, ability to rule out empty cassette strains, and validation on multiple swab types, provide additional convenience and ease-of-use to laboratories to support improved infection control outcomes.”

“MRSA is known as a genetically variable pathogen and for a diagnostics provider it is of utmost importance to improve test components able to detect emerging MRSA clones with high accuracy,” said Prof. Udo Reischl at the University of Regensburg in Germany. ”A rapid and more sensitive method for surveillance of MRSA represents a definite advantage for patient care and infection control programs, and Xpert MRSA NxG fulfils the current need for MRSA detection.”

Xpert MRSA NxG will begin shipping in countries accepting the CE-mark in April.  For more information on Cepheid’s GeneXpert Systems or the complete menu of Xpert tests, visit www.cepheid.com.

1 Grundmann H, et al. Emergence and resurgence of methicillin-resistant Staphylococcus aureus as a public-health threat. Lancet. 2006 Sep 2;368(9538):874-85.2 Köck R, et al. Systematic literature analysis and review of targeted preventive measures to limit healthcare-associated infections by methicillin-resistant Staphylococcus aureus. Euro Surveill. 2014 Jul 24;19(29).3 Paterson G.K., et al. The emergence of mecC methicillin-resistant Staphylococcus aureus. Trends Microbiol. 2014 Jan;22(1):42-7.

SOURCE Cepheid