The Food and Drug Administration (FDA) has authorized marketing of a new diagnostic test, cobas vivoDx MRSA (Roche Molecular Systems Inc), to detect methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization and aid in the prevention and control of MRSA infections in healthcare settings.

The cobas vivoDx MRSA test provides rapid phenotypic detection of MRSA colonization through bioluminescence using new bacteriophage technology. The diagnostic test allows healthcare professionals to detect MRSA from nasal swab samples in about 5 hours compared to 24-48 hours with traditional culture-based techniques. Earlier detection allows clinicians to identify patients who may need to be isolated or require additional decolonization efforts.

The FDA’s authorization for marketing was based on data from performance studies reviewed through the de novo premarket regulatory pathway. Findings from the studies showed that the cobas vivoDx MRSA test correctly identified MRSA in approximately 90% of samples with MRSA present, and correctly identified no MRSA in 98.6% of samples that did not have MRSA present. 

Related Articles

“Diagnostics that are able to provide accurate results more quickly can offer health care providers an advantage when trying to prevent and contain the spread of resistant bacteria,” said Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Today’s authorization adds a new tool in the fight to prevent and control MRSA in high-risk settings.


Continue Reading

For more information visit fda.gov.