The FDA granted marketing authorization of the Cobas vivoDx MRSA (Methicillin-resistant Staphylococcus aureus) test to Roche Molecular Systems Inc. The new diagnostic test based on bacterial viability and novel technology and allows faster evaluation of patients for colonization with MRSA bacteria. The authorization adds a new tool in the fight to prevent and control MRSA in high-risk settings. The Cobas vivoDx MRSA test uses a new bacteriophage technology based on bioluminescence to detect MRSA from nasal swab samples in as little as 5 hours compared to 24-48 hours for conventional culture. the Cobas vivoDx MRSA test correctly identified MRSA in approximately 90% of samples where MRSA was present and correctly identified no MRSA in 98.6% of samples that did not have MRSA present. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device. @ https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-diagnostic-test-uses-novel-technology-detect-mrsa-bacteria?utm_campaign=120519_PR_FDA%20authorizes%20novel%20MRSA%20test&utm_medium=email&utm_source=Eloqua
A novel technology to detect MRSA got the FDA authorization for sale
FDA authorizes marketing of diagnostic test that uses novel technology to detect MRSA bacteria
FDA authorized a new diagnostic test to detect MRSA bacterial colonization, a widespread cause of hospital-acquired infections.