Automated MRSA/SA Test Receives US FDA Approval

An automated real-time polymerase chain reaction (PCR) assay for the detection of methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) DNA directly from nasal swabs has been certified for diagnostic use in the United States.

The [US] Food and Drug Administration (FDA) has issued 510(k) clearance, which allows marketing as a diagnostic tool, for the Roche (Basel, Switzerland) cobas MRSA/SA Test for the early, simultaneous detection of MRSA and SA directly from nasal specimens.


The cobas MRSA/SA assay was developed for use on the cobas 4800 system. This system was designed to automatically perform real-time PCR for medium- to high-throughput laboratories (up to 384 samples a day). The system incorporates fully automated sample preparation from primary vials with ready-to-use, load-and-go reagents. No thawing or mixing is required and a full run of 94 samples can be set up in less than 20 minutes.

The cobas MRSA/SA Test joins the expanding US system menu that currently includes the cobas CT/NG Test (chlamydia/gonorrhea), cobas HPV Test, cobas BRAF V600 Mutation Test, and the cobas EGFR Mutation Test.

"Healthcare-associated infections continue to be a leading cause of mortality in US medical settings," said Paul Brown, head of Roche Molecular Diagnostics. "With the addition of the cobas MRSA/SA Test to our expanding menu of tests for the cobas 4800 System, Roche offers laboratories and clinicians a highly efficient molecular solution to aid in the overall management and prevention of healthcare-associated infections, leading to lower costs for hospitals and optimal patient care."

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