FDA authorisation for Roche’s four-in-one respiratory panel

Roche has announced today that the US Food and Drug Administration (FDA) has granted Emergency Use Authorisation (EUA) for its cobas Liat SARS-CoV-2, Influenza A/B and RSV nucleic acid test, an automated multiplex real-time polymerase chain reaction (RT-PCR) assay on the cobas Liat system.

Producing results in just 20 minutes on a compact analyser suitable for most healthcare settings, the test uses either a single nasopharyngeal or anterior nasal swab sample to confirm or rule out infection with SARS-CoV-2, influenza A virus, influenza B virus and respiratory syncytial virus (RSV).

“Diagnostics play a critical role in the fight against respiratory illness,” said Matt Sause, CEO of Roche Diagnostics. “We are proud to provide this innovative test to address the significant burden placed on healthcare systems. Now, healthcare professionals will be able to detect and differentiate these respiratory viruses within a single patient visit, enabling improved public health outcomes.”

Introducing rapid multiplex PCR diagnostic tests into near-patient care environments such as emergency departments, urgent care facilities, and physician office laboratories has the potential to provide swift and precise results, expediting clinical decision-making processes. This approach can help reduce unnecessary antibiotic usage, facilitate targeted treatment strategies, and ultimately enhance patient outcomes and healthcare system efficiency.

According to the US Centers for Disease Control and Prevention (CDC), respiratory diseases in the United States reached high levels during the most recent autumn and winter seasons, with SARS-CoV-2 causing the most emergency department visits.

The cobas Liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test authorised for emergency use further expands and complements Roche’s broad portfolio of single and multiplex tests intended to help diagnose and address the needs of patients presenting with symptoms of respiratory illness.

The cobas Liat system combines the cobas Liat analyser – an automated nucleic acid test instrument – with cobas Liat assay tubes to fully automate the testing process, simplify workflows, and enable healthcare professionals to perform molecular testing in a variety of near-patient settings with speed, reliability and minimal training. The system performs reagent preparation, target enrichment, inhibitor removal, nucleic acid amplification, PCR amplification, real-time detection, and result interpretation to automate the detection and quantification of nucleic acid targets in a biological sample in a single closed tube. Definitive results are generated in 20 minutes or less to aid in patient care decisions. The cobas Liat SARS-CoV-2, Influenza A/B and RSV assay complements existing tests for SARS-CoV-2, influenza A/B, influenza A/B and RSV, group A Streptococcus, and Clostridiodes difficile. Assays for other infectious diseases are currently in development.


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