Aug. 4, 2025—Roche announced FDA 510(k) clearance for its Cobas Respiratory 4-flex assay. The test uses the company’s TAGS (temperature-activated generation of signal) technology and provides PCR results for SARS-CoV-2, influenza A and B, and respiratory syncytial virus. TAGS uses multiplex PCR testing combined with color, temperature, and data processing to enable the detection and differentiation of multiple targets within a single optical channel.
The test runs on the Cobas 5800, 6800, and 8800 instruments. A digital reflex option, available on the Cobas 5800, allows for additional results to be obtained from the same test run, beyond the initial reported results. Digital reflex will be available on the Cobas 6800/8800 systems with software version 2.0, which is in development and not available in the United States.