Roche has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its cobas® Respiratory 4-flex assay, the first FDA-cleared test to feature Roche’s proprietary TAGS (Temperature-Activated Generation of Signal) technology. This innovation is designed to enhance respiratory diagnostics by improving efficiency and accuracy, allowing for faster, more targeted clinical decisions.
The new multiplex PCR assay detects and differentiates the four most common respiratory viruses—SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV)—from a single patient sample. By consolidating these targets into one streamlined test, the assay improves lab workflow and supports timely treatment initiation. It is compatible with Roche’s cobas 5800, 6800, and 8800 molecular systems, ensuring seamless integration into existing laboratory operations.
“The cobas Respiratory 4-flex represents a major step forward in respiratory diagnostics. With the power of TAGS technology, we are helping labs address current and future testing needs while conserving healthcare resources,” said Brad Moore, President and CEO of Roche Diagnostics North America.
One of the key features of the test is its customizable testing menu, which allows laboratories to tailor results based on physician orders and patient symptoms—often overlapping among respiratory infections. The assay also supports a “digital reflex” testing feature. For example, if only influenza A and B are initially requested and results return negative, additional results for SARS-CoV-2 or RSV can be reflexively reported from the same sample without the need for re-testing or repeat visits.
Our goal is to enable flexible, symptom-based testing that adapts to clinical realities. With TAGS technology, we can detect more targets using fewer resources, helping labs keep pace with the evolving respiratory landscape,” said Dr. Denise Heaney, Chief Medical Partner, Molecular Solutions and Infectious Disease at Roche Diagnostics.
TAGS (Temperature-Activated Generation of Signal) is Roche’s novel signal generation system that enables multiplex PCR testing within a single optical channel. By combining temperature control, colorimetric differentiation, and advanced data processing, TAGS makes it possible to detect and differentiate multiple viral targets simultaneously with high accuracy.
The cobas Respiratory 4-flex test provides qualitative detection and differentiation of SARS-CoV-2, influenza A and B, and RSV in nasopharyngeal swabs from symptomatic patients. It supports diagnostic decisions for individuals based on both clinical presentation and epidemiological risk, helping clinicians quickly pinpoint the cause of respiratory illness.
This latest addition strengthens Roche’s already comprehensive respiratory testing portfolio, which spans both singleplex and multiplex assays for viral and bacterial infections, supporting better patient care across all stages—from diagnosis to management.