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6th December 2019  Author: Paul Carton

FDA Approves Bacteriophage Bioluminescence Test to Detect MRSA


The FDA has granted Roche Molecular Systems Inc. de novo marketing authorisation for its MRSA diagnostic test that uses new Smarticles technology; a bioluminescence bacteriophage-based assay which produces light in viable MRSA colonies.

The Cobas vivoDx MRSA test can detect MRSA colonisation from a nasal swab sample in just 5 hours as compared to 24-48 hours for conventional culture. The FDA reviewed data from performance studies in which 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 MRSA test which will work on the Roche Cobas vivoDx system incorporating Smarticles technology. This technology involves the use of a shell from an MRSA-specific bacteriophage, and custom-designed DNA that once taken up by viable MRSA bacteria produces light. Roche acquired Smarticles technology when they purchased GeneWEAVE Biosciences for approximately ½ a billion dollars.


    

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Date Published: 6th December 2019

Source article link: https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-diagnostic-test-uses-novel-technology-detect-mrsa-bacteria


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