FDA Clears First TAGS-Powered Respiratory Panel for Simultaneous Detection of SARS-CoV-2, Flu, and RSV
Cleared for use on Roche’s cobas® systems, the new PCR test supports syndromic respiratory diagnostics with customizable panels and digital reflex capability
Highlights:
- Used with the cobas® 5800, 6800, and 8800 systems, cobas Respiratory 4-flex simultaneously detects and differentiates the four most common respiratory viruses, helping to ensure confidence in diagnosis.
- The new cobas Respiratory 4-flex offers an innovative syndromic PCR testing solution, providing labs flexibility in customizing their menu panel.
- The customized panel test includes a "digital reflex"* option that allows for additional results to be obtained from the same test run, beyond the initial reported results.
Indianapolis, August 4, 2025 /PRNewswire/ — Roche today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for the cobas® Respiratory 4-flex. This is the first FDA-cleared assay utilizing Roche's innovative TAGS (Temperature-Activated Generation of Signal) technology, designed to streamline respiratory testing, and to ensure timely and accurate diagnoses for patients.
The new test provides accurate PCR results for the four most common respiratory viruses: SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV). This enables physicians to promptly initiate targeted treatment plans to improve patient care. The test consolidates these four key targets into a single, efficient assay, simplifying laboratory workflows and optimizing resource use. It integrates seamlessly with Roche's cobas 5800, 6800, and 8800 molecular lab instruments.
"The cobas Respiratory 4-flex assay offers a significant technological advancement that empowers labs to address evolving respiratory testing demands now and in the future," said Brad Moore, President and CEO of Roche Diagnostics North America. "The expanded testing capabilities, enabled by TAGS technology, will allow labs to deliver reliable and relevant patient testing, while also optimizing healthcare resources."
With its customizable testing menu, cobas Respiratory 4-flex enables laboratories to tailor testing to physician orders and patient needs, reducing the need for repeat healthcare visits and tests. The test includes a "digital reflex"* option, which allows for additional testing from the same sample. For example, if the physician requests influenza A and B and the results are negative, a digital reflex can request results for SARS-CoV-2 or RSV, focusing on relevant tests for the patient. While raw data for all targets is generated and available, only requested results are analyzed and reported, ensuring targeted and efficient testing.
"Our goal for the Respiratory 4-flex is to allow labs to customize testing based on clinical needs, patient symptoms, which are often similar, and to better support a constantly shifting respiratory landscape," said Denise Heaney, PhD, Chief Medical Partner, Molecular Solutions and Infectious Disease at Roche Diagnostics. "TAGS technology allows for the detection of more targets on a high-throughput platform, which supports diagnostic stewardship while reaching a broader patient population."
This launch further expands Roche's respiratory portfolio, which includes a broad range of single-plex and multi-plex assays for respiratory viral and bacterial infections, supporting patient testing needs across the continuum of care.
TAGS (Temperature-Activated Generation of Signal) technology
Leveraging Roche's innovative TAGS technology, cobas Respiratory 4-flex lays the groundwork for future expanded testing capabilities. Developed by Roche scientists, TAGS technology uses multiplex polymerase chain reaction (PCR) testing, combined with color, temperature and data processing, to enable the detection and differentiation of multiple targets within a single optical channel.
About cobas Respiratory 4-flex
The cobas Respiratory 4-flex runs on the cobas 5800, 6800, and 8800 systems. The test offers qualitative detection and differentiation of SARS-CoV-2, influenza A and B, and respiratory syncytial virus (RSV) in nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection, along with clinical and epidemiological risk factors.