Roche Respiratory Panel Nabs FDA Clearance

Original from: 360dx

Roche on Monday announced that its Cobas Respiratory 4-flex test for SARS-CoV-2, influenza A/B, and respiratory syncytial virus has received clearance from the US Food and Drug Administration.

The test simultaneously detects and differentiates between the four viruses and runs on the Cobas 5800, 6800, and 8800 PCR-based systems. The assay uses Roche's new Temperature-Activated Generation of Signal (TAGS) technology and includes a digital reflex option that allows for additional results to be obtained from the same test run beyond the initial reported results, Roche said in a statement. The firm added that in the US, digital reflex testing will only be available on the Cobas 5800 system at launch. It will be added to the Cobas 6800/8800 systems with software version 2.0, which it said is in development and not available in the US. 

"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 Roche Diagnostics North America President and CEO Brad Moore. "The expanded testing capabilities, enabled by TAGS technology, will allow labs to deliver reliable and relevant patient testing, while also optimizing healthcare resources."

The TAGS technology uses multiplex PCR testing combined with color, temperature, and data processing to enable the detection and differentiation of multiple targets within a single optical channel, Roche noted.

"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, chief medical partner for 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."

Source: Roche Respiratory Panel Nabs FDA Clearance