Thermo Fisher Scientific has announced the 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel. This innovative molecular clinical test provides healthcare professionals with a single, reliable testing solution for four of the most prevalent respiratory viruses, including SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV). Designed to meet the challenges of flu season, the real-time PCR-based multiplex test ensures accurate detection and differentiation of these viruses while enabling the identification of co-infections.

Respiratory illnesses often present overlapping symptoms, making it challenging to diagnose the specific pathogen responsible for an illness based on clinical presentation alone. Leveraging the proven reliability of Thermo Fisher's COVID-19 test, this new panel enables detection of multiple respiratory viruses from a single patient sample. The solution delivers fast and accurate results in as little as three hours, empowering clinicians to make informed decisions and tailor treatments to their patients' needs more effectively.

The clearance of this test is particularly timely as the flu season reaches its peak and RSV cases continue to rise. "This test provides crucial support to clinical communities looking for reliable and efficient testing solutions," stated Rosy Lee, President, Genetic Sciences at Thermo Fisher Scientific. By simplifying workflows and enhancing diagnostic accuracy, the TaqPath COVID-19, Flu A, Flu B, RSV Select Panel supports healthcare systems in their efforts to manage respiratory illnesses more effectively.

Designed with clinical laboratories, primary care settings, and infectious disease surveillance in mind, the test is supported by an integrated and streamlined diagnostic workflow. The process begins with the KingFisher™ Apex Dx system, which ensures precise results and seamless data management. For sample preparation, the Applied Biosystems MagMAX™ Dx Viral/Pathogen NA Isolation Kit extracts high-quality nucleic acids from human respiratory specimens. The test is then performed on the Applied Biosystems QuantStudio™ 5 Dx Real-Time PCR System, a compact, cost-effective solution offering proven performance for clinical laboratories.

The panel's reagent mix includes assays for SARS-CoV-2, influenza A, influenza B, and RSV, along with positive and negative controls, a 1-Step Master Mix, and an internal RNaseP endogenous control for human sample collection quality assurance. Results are analyzed using the Applied Biosystems Diomni Enterprise Software v4.1, a comprehensive workflow solution that connects all stages of real-time PCR testing within a single ecosystem, ensuring accuracy and compliance with diagnostic regulatory standards.

With the TaqPath COVID-19, Flu A, Flu B, RSV Select Panel, Thermo Fisher Scientific continues to demonstrate its commitment to delivering innovative diagnostic solutions that meet the evolving needs of clinical laboratories and healthcare professionals. This clearance represents a significant advancement in the fight against respiratory illnesses, helping clinicians streamline workflows, improve diagnostic confidence, and enhance patient outcomes during challenging respiratory seasons.