FDA approves Roche's MRSA/SA Test system

A method developed by Roche Molecular Diagnostics to test nasal specimens simultaneously for methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-sensitive Staphylococcus aureus (SA) has received 510(k) clearance from the Food and Drug Administration, Roche said Monday.

"Numerous successful surveillance programs have led to a significant decrease in the rate of MRSA clinical infection in many organizations, and a dramatic reduction in post-operative surgical infections when screening for SA is done. Importantly, the fight against health-care-associated infections continues to advance, as evidenced by this new test that can rapidly detect both MRSA and SA in a single assay," Lance Peterson, director of microbiology and infectious-diseases research at NorthShore University HealthSystem and a clinical professor of pathology and medicine at the University of Chicago's Pritzker School of Medicine, said.

The cobas MRSA/SA Test uses the 4800 testing system. A lab tech simply de-caps and loads the sample vial into the system.

"Health-care-associated infections continue to be a leading cause of mortality in U.S. medical settings," Paul Brown, head of Roche Molecular Diagnostics, said. "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 health-care-associated infections, leading to lower costs for hospitals and optimal patient care."