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Home Industry News Roche’s MRSA test approved by the FDA

Roche’s MRSA test approved by the FDA

10th December 2019

The marketing of Roche’s Methicillin resistant Staphylococcus aureus (MRSA) diagnostic test, cobas vivoDX, has been approved by the Food and Drug Administration (FDA). The test has been developed to detect MRSA more quickly and efficiently than current techniques, so that it can regulate the spread of infection, by identifying patients who need intensified precautions such as isolation, therefore assisting with the overall prevention of spreading in healthcare sites. In order to achieve this, the test conducts nasal swab samples through a new bacteriophage technology based on bio-luminescence. Previous tests have shown that the detection of MRSA can be conducted in as little as five hours.

The FDA observed the data from the cobas vivoDx test and discovered that it correctly identified that there was no MRSA present in ninety-eight point six percent of samples that didn’t have MRSA as well as correctly identifying that MRSA was present in ninety-percent of samples that did had MRSA.

Director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, Tim Stenzel, stated: “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 anti-microbial resistance in order to better protect patients against this ongoing public health challenge.”

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