INDIANAPOLIS — Roche has earned FDA clearance for a new lab test that can check for COVID‑19, flu A, flu B, and RSV — all at once, from a single sample.
Called the cobas® Respiratory 4‑flex, the test is the first to use Roche’s new TAGS technology, designed to give faster, more reliable results for the viruses most likely to send patients to the doctor in fall and winter. It runs on Roche’s high capacity cobas testing systems, which are already used in many hospitals and labs.
The test also offers something new: a customizable menu. Doctors and labs can focus on the viruses most relevant to a patient’s symptoms and even add other results from the same test without needing to collect a new sample. Roche says this can save time, reduce extra appointments, and help patients get the right treatment sooner.
“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,” said 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.”
Roche says the launch will help labs and clinics prepare for a busy respiratory virus season, when COVID-19, flu, and RSV often spread simultaneously.
