On Jun. 10, 2024, Roche announced that the U.S. Food and Drug Administration (FDA) had 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 analyzer 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).

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. Hospitalizations 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 hospitalizations caused by SARS-CoV-2, influenza and RSV.^9,10 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 authorized 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.