Cepheid bags FDA nod for next-gen MRSA test

The next-gen MRSA infection control test runs on Cepheid's GeneXpert systems. Image: Cepheid

Molecular diagnostics player Cepheid scored an FDA OK for its next-gen MRSA infection control test, developed to combat new strains of MRSA that have emerged over the past few years.

The test, Xpert MRSA NxG, is an accurate, on-demand, molecular test for methicillin-resistant Staphylococcus aureus, which returns results within an hour, according to a statement. It runs on the company's GeneXpert systems. Emerging MRSA strains tend to elude detection from traditional assays and threaten the progress made against hospital-acquired infections in recent years. The new test aims to plug this gap.

It is based on a library of MRSA strains from around the world, covering more strains than existing tests. The test lowers the likelihood of false positives thanks to a new design incorporating updated PCR primers and probes that detect different strains—mecA and mecC—of the virus, according to the statement.

"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," said Dr. Fred Tenover, Cepheid's vice president for scientific affairs, in the statement. "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."

Using rapid molecular diagnostics—such as the Xpert MRSA NxG—alongside infection prevention measures, were shown in a study to cut down on the spread of MRSA in healthcare settings, Cepheid said. In addition to MRSA, Cepheid also markets tests for norovirus, infectious disease and sexual health.

In September, Danaher announced that it had inked a deal with Cepheid to acquire it for approximately $4 billion. The transaction closed in November. Danaher, a serial acquirer, spent about $1 billion on 14 acquisitions in 2013, dropped $30 million on Applied Spectral Imaging last year and bought Pall Corporation for $13.8 billion in May.