December 05, 2019
The US Food and Drug Administration (FDA) has approved a new, faster diagnostic test based on bacterial viability and a novel technology to detect methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization, a common cause of hospital-acquired infections.
The cobas vivoDx MRSA diagnostic test, from Roche Molecular Systems, may allow healthcare providers to evaluate patients for colonization with MRSA bacteria significantly faster than traditional culture-based techniques, the FDA said in a news release.
The cobas vivoDx MRSA test uses a new bacteriophage technology based on bioluminescence to detect MRSA from nasal swab samples in as few as 5 hours compared with 24 to 48 hours for conventional cultures.
"Diagnostics that are able to provide accurate results more quickly can offer healthcare providers an advantage when trying to prevent and contain the spread of resistant bacteria," 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, said in the release.
The cobas vivoDx MRSA test "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," said Stenzel.
In performance testing, the cobas vivoDx MRSA test correctly identified MRSA in about 90% of samples where MRSA was present and correctly identified no MRSA in 98.6% of samples free of MRSA.
"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 decolonization efforts," the FDA said.
In 2017, there were more than 323,000 cases of MRSA in hospitalized patients and more than 10,000 deaths, according to the US Centers for Disease Control and Prevention.
The FDA reviewed the cobas vivoDx MRSA test under the de novo premarket review pathway, a regulatory pathway for new types of devices considered low-to-moderate risk. The FDA will develop special controls in addition to general controls that will help ensure the safety and effectiveness of the test.