SWITZERLAND – Roche has launched its latest diagnostic test, the first to use its innovative TAGS (temperature-activated generation of signal) technology to detect up to 12 respiratory viruses at once.
Available for laboratories operating Roche’s Cobas 5800, 6800, and 8800 molecular diagnostic analyzers, the test can identify pathogens like influenza A and B, RSV, and COVID-19.
This new diagnostic tool is currently available in countries that accept CE marks, with Roche planning to file for U.S. FDA clearance later this year.
Roche has projected that the respiratory molecular diagnostics market could reach 1.7 billion Swiss francs (about US $2 billion) by 2027, revealing these estimates at a diagnostics event in May.
The launch aligns with Roche’s strategy to meet rising demand for flexible, high-throughput respiratory testing.
Innovative technology and flexible testing options
Typically, a single PCR test can detect five targets (four viruses and one control), but Roche’s TAGS technology increases this capacity to 15 targets by distinguishing up to three viruses in the same color using temperature variations.
Nico Michel, Roche’s Lifecycle Leader for infectious diseases in molecular labs, emphasized the test’s adaptability to high demand and seasonal needs: “With this first TAGS assay, we make respiratory infection testing fully automated, and we enable our customers to easily scale and tackle seasonal high demand,” he explained.
In addition to its expanded capacity, the new test offers “digital reflexing,” a feature that speeds up targeted diagnostics.
According to Roche, digital reflexing “enables the generation of additional results instantly or within seconds” without requiring a new sample or a re-run.
This feature allows clinicians to select specific pathogens to test for, providing fast, targeted answers, especially during peak respiratory seasons.
Future plans and market impact
The respiratory test is the first of several assays Roche intends to release using TAGS technology, with multiple countries already initiating local registrations.
Roche sees this innovation as part of a broader effort to advance syndromic testing capabilities in the diagnostics field.
Michel confirmed, “This is the first of several future assays based on the technology,” highlighting Roche’s commitment to flexible testing solutions.
The launch of the cobas Respiratory flex test further strengthens Roche’s comprehensive portfolio in respiratory diagnostics, which also includes the newly rebranded cobas eplex system, a world-class solution for multiplex and syndromic testing.
This launch also follows recent news that the FDA had granted Emergency Use Authorization for Roche’s four-in-one cobas liat test for SARS-CoV-2, Influenza A/B & RSV enabling rapid, multiplex PCR diagnostic tests to be undertaken in emergency departments, urgent care facilities and physician office labs.
