Roche Molecular Systems has secured marketing authorisation from the US Food and Drug Administration (FDA) for a new diagnostic test to detect Methicillin-resistant Staphylococcus aureus (MRSA) bacteria.
The health care professionals may be able to assess patients for MRSA bacteria colonisation more quickly with the cobas vivoDx MRSA diagnostic test than traditional culture-based techniques.
The test uses novel bacteriophage technology based on bioluminescence to detect MRSA from nasal swab samples within five hours as against between 24 and 48 hours for conventional culture.
MRSA is a type of bacteria that may cause serious illness and even death if a patient develops an infection.
As per the estimates of Centers for Disease Control and Prevention (CDC), around 5% of patients in the US hospitals carry the MRSA bacteria, even though many of those that carry the bacteria do not develop infections.
According to the CDC estimates, there were over 323,000 MRSA cases in hospitalised patients in the country and over 10,000 deaths in 2017.
The cobas vivoDx MRSA test will prevent and control MRSA infections in healthcare settings
Cobas vivoDx MRSA test facilitates in identifying those patients requiring better precautions for infection control through isolation and additional decolonisation efforts.
The data from the performance studies assessed by the FDA revealed that the Roche’s test accurately detected MRSA in around 90% of samples where MRSA was present, as well as correctly identified no MRSA in 98.6% of samples that did not have MRSA.
The FDA used the de novo premarket review pathway to analyse the cobas vivoDx MRSA test. It is a regulatory pathway for a new type of low-to-moderate-risk devices.
FDA’s Center for Devices and Radiological Health in vitro diagnostics and radiological health office director Dr Tim Stenzel 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.
“Today’s authorization 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.”
In September, Roche received FDA approval or its cobas Babesia test to run on the cobas 6800/8800 Systems for individual blood donation testing.
