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FDA Grants Marketing Authorization for Novel MRSA Diagnostic Test

The US Food and Drug Administration (FDA) has granted marketing authorization for the cobas vivoDX MRSA diagnostic test. The authorization was granted to Roche Molecular Systems Inc.

The test is a new diagnostic tool that uses bacterial viability and a novel technology to detect bacterial colonization of Methicillin-resistant Staphylococcus aureus (MRSA).

The new test uses bacteriophage technology that is based on bioluminescence to detect MRSA from nasal swab samples. This process can be conducted in as little as 5 hours which expedites the current conventional culturing timeline of 24-48 hours.

Speeding up the diagnosis time may help prevent the spread of MRSA, which occurred in more than 323,000 hospitalized patients in the United States in 2017. The cobas vivoDX MRSA diagnostic test is intended to assist in preventing and controlling MRSA in health care settings to identify patients who require enhanced precautions and decolonization efforts.

Authorization of the device was based on data from performance studies. In these studies, the test correctly identified MRSA in approximately 90% of samples where the bacteria was present and correctly identified no MRSA in 98.6% of samples where the bacteria was not present.

“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, said in the FDA’s statement. “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.”

The test was reviewed by the FDA through the de novo premarket review pathway. According to the agency’s statement, special controls will be established for tests of this type which include requirements for labeling and addressment of certain risk such as false positives.
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