Roche four-in-one molecular test for SARS-CoV-2, Influenza A/B viruses and RSV receives U.S. FDA Emergency Use Authorization

Original from: Roche

· The test uses highly sensitive PCR technology, requiring only a single nasal-swab sample to provide rapid, accurate qualitative detection and differentiation among four of the most prevalent respiratory viruses for which differential diagnosis can drive appropriate treatment.

· Enables healthcare professionals to make confident clinical decisions and promptly determine appropriate treatment, with definitive results reported in just 20 minutes.

· ​Expands Roche’s extensive molecular point of care testing portfolio, offering greater flexibility to meet testing needs amid evolving regional prevalence of respiratory infections.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its cobas® liat SARS-CoV-2, Influenza A/B & 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 labs 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 U.S. 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. Hospitalisations due to respiratory illness place a strain on hospitals and can result in delayed diagnosis and treatment for patients. In the 2023-2024 respiratory season, infants, children, and adults ages 65 and older were observed to have the highest rates of emergency department visits and hospitalisations caused by SARS-CoV-2, influenza, and RSV. Nationwide, the percentage of recent total deaths due to these respiratory viruses was highest among patients 65 and older.

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, including the following assays: cobas® SARS-CoV-2, cobas® Strep A, cobas® SARS-CoV-2 & Influenza A/B, and cobas® Influenza A/B & RSV for use on the cobas liat system. In 2025, Roche intends to seek FDA 510(k) clearance and a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver in the United States for the new test, with plans for commercial launch in other markets worldwide following CE-IVDR approval.

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Source: Roche four-in-one molecular test for SARS-CoV-2, Influenza A/B viruses and RSV receives U.S. FDA Emergency Use Authorization