Saturday, June 15, 2024

Roche’s Influenza, SARS-CoV-2, and RSV Test Receives FDA Emergency Use Authorization

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Roche announced 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 Respiratory Viruses test. This test uses highly sensitive PCR technology, requiring only a single nasal-swab sample to detect and differentiate among SARS-CoV-2, influenza A and B viruses, and respiratory syncytial virus (RSV). Results are reported in just 20 minutes, enabling healthcare professionals to make confident clinical decisions quickly.

The cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is designed to improve patient outcomes by providing rapid, accurate results. The test operates on the cobas® liat system, which is compact and suitable for various healthcare settings. This diagnostic tool addresses a critical need, especially during peak seasons of respiratory illnesses, by reducing the strain on healthcare systems and expediting clinical decision-making processes. With this test, healthcare providers can promptly determine appropriate treatments, reducing unnecessary antibiotic usage and enhancing overall patient care.

Introducing rapid multiplex PCR diagnostic tests into near-patient care environments such as emergency departments, urgent care facilities, and physician office labs can transform the management of respiratory illnesses. The cobas liat system automates the testing process, including reagent preparation, target enrichment, nucleic acid amplification, and real-time detection. This automation simplifies workflows and minimizes the need for extensive training, making it accessible for various healthcare settings. The ability to deliver definitive results in 20 minutes or less enables healthcare professionals to make timely and informed decisions, improving patient outcomes and operational efficiency.

The Role of Cobas Liat Test in Managing Respiratory Illnesses

According to the U.S. Centers for Disease Control and Prevention (CDC), respiratory diseases, including SARS-CoV-2, influenza, and RSV, significantly impact healthcare systems, especially during autumn and winter seasons. In the 2023-2024 respiratory season, high rates of emergency department visits and hospitalizations were observed among infants, children, and adults aged 65 and older. The cobas liat test helps alleviate this burden by enabling swift and precise diagnosis, ultimately improving patient outcomes and healthcare efficiency.

Respiratory illnesses pose a significant challenge to healthcare systems, particularly during peak seasons when hospitals are often overwhelmed with cases. SARS-CoV-2, influenza, and RSV are major contributors to these surges, causing a substantial number of emergency department visits and hospitalizations. The ability to quickly and accurately diagnose these infections is crucial in managing patient flow and ensuring that resources are used effectively. By providing a reliable diagnostic tool, the cobas liat test helps healthcare providers to swiftly identify the cause of respiratory symptoms and implement appropriate treatment plans, reducing the overall burden on the healthcare system.

The cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test complements Roche’s extensive molecular point-of-care testing portfolio, which includes single and multiplex tests for various respiratory pathogens. Roche’s commitment to advancing diagnostic solutions is evident in its comprehensive range of tests designed to address the evolving needs of healthcare systems worldwide. The company’s portfolio includes assays for SARS-CoV-2, Strep A, Influenza A/B, and RSV, among others. By expanding its diagnostic capabilities, Roche aims to provide healthcare professionals with the tools they need to manage respiratory illnesses effectively.


FDA Approval and CLIA Waiver for Cobas Liat Influenza Test in 2025

Roche plans to seek FDA 510(k) clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver in 2025, followed by a commercial launch in other markets after CE-IVDR approval. This strategic move will further enhance the accessibility and availability of the cobas liat test, enabling more healthcare providers to benefit from its rapid and accurate diagnostic capabilities. The company’s ongoing commitment to innovation and quality ensures that its diagnostic solutions remain at the forefront of healthcare advancements.

Roche’s focus on diagnostic innovation is driven by its dedication to improving patient care and outcomes. The development and approval of the cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is a testament to the company’s ability to respond to urgent healthcare needs with advanced technological solutions. By continuing to expand its diagnostic portfolio, Roche is poised to play a crucial role in the global effort to combat respiratory illnesses and other infectious diseases.

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Resource: Roche, June 10, 2024

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