Roche’s TAGS technology enables simultaneous detection of 12 respiratory viruses, including influenza A, influenza B, respiratory syncytial virus (RSV), and COVID-19.
Cobas and TAGS Technology
The September 24 announcement stated that users of Roche’s Cobas 5800, 6800, and 8800 molecular diagnostic analyzers can detect pathogens, including influenza A, influenza B, RSV, and COVID-19. Laboratories in countries that accept the CE mark can utilize this testing method. The company is targeting the respiratory molecular diagnostics market, which is expected to reach CHF 1.7 billion by 2027, equivalent to approximately RMB 14 billion.
At a diagnostics investor event in May, Roche shared this forecast and detailed its Temperature-Activated Signal Generation (TAGS) technology. According to Roche, a single PCR test typically detects up to five targets—four viruses and one control—each represented by a different color. TAGS technology allows users to measure three targets of the same color, visible at different temperatures, detecting up to 15 targets in total.
Nico Michel, Head of Roche Molecular Laboratory Infectious Disease Lifecycle, highlighted the test’s advantages and pricing strategy at the May investor event.
“With the first TAGS test…we have achieved fully automated respiratory infection testing, enabling our customers to easily scale up and meet seasonal high demand. We also introduced an innovative pricing strategy that allows flexible ordering and cost-effective use of digital reflex,” Michel stated.
510(k) Submission Expected in Q4
Clinicians can specify which pathogens to test for, such as using the test during winter months when certain respiratory viruses are prevalent, to determine whether adult patients have flu or COVID-19. Typically, targeted testing might delay diagnosis if follow-up tests are needed. Roche claims that digital reflex eliminates this delay “by generating additional results immediately or within seconds, without the need to collect another sample or rerun an existing sample.”
Several countries have already initiated local registrations for respiratory testing. Roche plans to submit for 510(k) clearance in the U.S. in Q4, marking the next major step in its regulatory roadmap. The company identified this test as a growth driver at its Diagnostics Day event.
The launch of respiratory testing is part of a broader effort to enable flexible, comprehensive testing using TAGS technology. Michel noted that the new test is the “first of several future tests” based on this technology.
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