FDA authorises Roche's cobas dual COVID-19, influenza test for emergency use

Roche announced Friday that the FDA issued an emergency-use authorisation to its cobas SARS-CoV-2 and influenza A/B test for use on cobas 6800/8800 systems. According to the company, the test can simultaneously detect and differentiate all three viruses with a single sample. "With the approaching influenza season, this new test is particularly important as SARS-CoV-2 and influenza infections can hardly be differentiated by symptoms alone," noted Thomas Schinecker, CEO of Roche's diagnostics unit.

The RT-PCR assay, which is also available in markets accepting the CE mark, can detect whether a person has SARS-CoV-2 or one of the two forms of influenza from nasal or nasopharyngeal swab samples. Meanwhile, Roche said the analysers can provide up to 96 results in approximately three hours, adding that in an eight-hour shift, the cobas 6800 system can process 384 results, while cobas 8800 can process 1056.

The company recently announced it was launching a 15-minute SARS-CoV-2 antigen test in Europe later in September, and that it also intends to apply for an emergency-use authorisation from the FDA.

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