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Cepheid gets FDA approval for next generation MRSA infection control test

MDBR Staff Writer Published 20 December 2016

Cepheid has secured approval from the US Food and Drug Administration (FDA) for its next generation methicillin-resistant Staphylococcus aureus (MRSA) infection control test, Xpert MRSA NxG.

Xpert MRSA NxG is said to be the accurate, on-demand and molecular test, which can provide results in around an hour.

The company has developed new test by using an extensive library of MRSA strains collected from across the globe.

Updated PCR primers and probes, which were integral part of the new test, will enable to detect both mecA and mecC strains. It helps to reduce the frequency of false-positive results due to empty cassette strains.

According to Cepheid, the test has been validated for use with both ESwab (Copan) and rayon swabs.

The firm’s GeneXpert systems will run Xpert test cartridges, and holds capacity to carry out one to eighty Xpert tests at the same time.

Xpert test menu is comprised of healthcare-associated infections, sexual health, critical infectious disease and oncology.

Cepheid scientific affairs vice president Dr Fred Tenover said: "MRSA surveillance remains a critical infection prevention activity for healthcare facilities and one that is challenged by the continued evolution of target sequences within MRSA.

"Fortunately, our global MRSA surveillance initiative has helped us keep ahead of the curve by alerting us to the emergence of novel strain types, enabling us to design a more comprehensive assay that takes into account major shifts, like the emergence of mecC, as well as more subtle changes in the SCCmec targets."