Roche Diagnostics has received FDA clearance for its cobas® Respiratory 4-flex test, and this development marks the first commercial application of the brand’s proprietary TAGS — also known as Temperature-Activated Generation of Signal — technology.

Roche Diagnostics’ multiplex PCR assay simultaneously detects and differentiates four major respiratory pathogens — SARS-CoV-2, influenza A, influenza B, and RSV — and provides clinicians with rapid, accurate results to guide treatment decisions. Designed for use with Roche’s cobas 5800, 6800, and 8800 laboratory systems, the respiratory test streamlines diagnostic workflows by consolidating multiple targets into a single run. The ‘digital reflex’ feature, which enables labs to retrospectively analyze additional targets from the same sample without requiring new tests, enhances efficiency and reduces patient retesting. The assay’s customizable panel also allows labs to tailor testing based on clinical needs.

Image Credit: Roche Diagnostics