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FDA authorizes marketing of diagnostic test cobas vivoDx that uses novel technology to detect Methicillin-resistant Staphylococcus aureus (MRSA) bacteria

Dec 05, 2019: Roche Molecular Systems Inc. received U.S. Food and Drug Administration approval for marketing of a new diagnostic test (Cobas vivoDx) based on bacterial viability and novel technology to detect Methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization to prevent and control MRSA in high-risk settings.

If a patient develops an infectionwith MRSA can lead to serious illness and even death. According to the Centers for Disease Control and Prevention (CDC), Not more than 5% of U.S. hospital patients carry the MRSA bacteria and many of those that carry the bacteria do not develop infections.

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The cobas vivoDx MRSA test uses a new bacteriophage technology which is based on bioluminescence in order to detect MRSA from nasal swab samples in as little as 5 hours compared to 24-48 hours for conventional culture.

The FDA reviewed data from the performance studies in which the cobas vivoDx MRSA test precisely identified MRSA in roughly 90% of samples where MRSA was present and correctly identified no MRSA in 98.6% of the samples that didn’t have MRSA present. https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-diagnostic-test-uses-novel-technology-detect-mrsa-bacteria

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