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.
