New Test Provides Accurate PCR results for Four Most Common Respiratory Viruses

Delays in diagnosis can hamper the prompt initiation of appropriate treatment, contributing to repeated healthcare visits and inefficient testing workflows. Laboratories have long struggled with rigid test panels that fail to align with evolving respiratory demands or specific clinical needs. Now, an innovative syndromic PCR testing solution can simultaneously detect and differentiate these four most common respiratory viruses, helping to ensure confidence in diagnosis.

Roche Diagnostics’ (Basel, Switzerland) new cobas Respiratory 4-flex offers qualitative PCR-based detection and differentiation of SARS-CoV-2, influenza A and B, and RSV from nasopharyngeal swab specimens. The test uses the company’s proprietary TAGS (Temperature-Activated Generation of Signal) technology which enables multiplex PCR testing with the ability to detect multiple viral targets within a single optical channel using a combination of color, temperature, and advanced data processing. A notable feature is the "digital reflex" option, which allows clinicians to obtain additional results from the same test run if initial target results are negative—streamlining patient care and reducing the need for re-testing. Laboratories can also customize the test panel based on physician orders and clinical requirements, allowing for flexible, targeted diagnostics.

By combining TAGS technology with high-throughput capabilities and customizable panels, the test supports diagnostic stewardship and broader patient access. The cobas Respiratory 4-flex test is compatible with Roche’s cobas 5800, 6800, and 8800 systems and has been granted FDA 510(k) clearance, making it well-positioned to improve respiratory diagnostics across healthcare settings. Roche plans to build on this innovation by expanding its respiratory portfolio to address future needs for viral and bacterial testing, leveraging the groundwork laid by this platform to develop further multiplex diagnostic solutions.

"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."

"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," added Denise Heaney, Ph.D., 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."