FDA approves new MRSA diagnostic test

The Food and Drug Administration (FDA) has authorised marketing of a diagnostic test based on bacterial viability and novel technology to detect MRSA.

The cobas vivoDx MRSA diagnostic test may allow healthcare professionals to evaluate patients for colonisation with MRSA bacteria more quickly than traditional culture-based techniques when such testing is needed. Market authorisation has been granted to Roche Molecular Systems. 

Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said: “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. The authorisation adds a new tool in the fight to prevent and control MRSA in high-risk settings. The FDA remains committed to supporting efforts to address antimicrobial resistance in order to better protect patients against this ongoing public health challenge.” 

The cobas vivoDx MRSA test uses a bacteriophage technology based on bioluminescence to detect MRSA from nasal swab samples in as little as five hours. Diagnostic tests that can more quickly and easily detect MRSA could benefit patient care and may help healthcare providers prevent the spread of MRSA. 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. The cobas vivoDx MRSA test is intended to aid in the prevention and control of MRSA infections in healthcare settings and can be used to identify patients needing enhanced precautions for infection control such as isolation and additional decolonisation efforts.

The FDA reviewed the cobas vivoDx MRSA test through the de novo premarket review pathway, a regulatory pathway for low-to-moderate-risk devices of a new type.