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FDA authorises marketing of diagnostic test 

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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

The US Food and Drug Administration authorised marketing of a new diagnostic test based on bacterial viability and novel technology to detect Methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization, a widespread cause of hospital-acquired infections. 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.

“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,” said Tim Stenzel, Director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Today’s 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 new bacteriophage technology based on bioluminescence to detect MRSA from nasal swab samples in as little as five hours compared to 24-48 hours for conventional culture. 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 per cent of samples where MRSA was present and correctly identified no MRSA in 98.6 per cent of samples that did not have MRSA present. The cobas vivoDx MRSA test authorised today 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. Along with this authorisation, the FDA is establishing special controls for tests of this type, including requirements relating to labelling and design verification and validation to address certain risks, such as false positives.  When met, the special controls, along with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.

The FDA granted marketing authorisation of the cobas vivoDx MRSA test to Roche Molecular Systems Inc.

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