Roche receives FDA EUA for the cobas SARS-CoV-2 & influenza A/B test

Sept. 8, 2020

Roche announced that the cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas 6800/8800 systems has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), according to a press release from Roche. This test is intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A and Influenza B in patients suspected by their healthcare provider of having respiratory viral infection consistent with COVID-19. Additionally, it is available in markets accepting the CE mark.

“With the approaching flu season, this new test is particularly important as SARS-CoV-2 and influenza infections can hardly be differentiated by symptoms alone. Now, with a single test, healthcare professionals can confidently provide the right diagnosis and most effective treatment plan for their patients,” said Thomas Schinecker, CEO of Roche Diagnostics.

Roche’s widely-available, fully-automated cobas 6800/8800 systems, which are used to perform the SARS-CoV-2 & Influenza A/B Test, offer the fastest time to results with the highest throughput and the longest walkaway time available among automated molecular platforms. The systems provide up to 96 results in about three hours and 384 results for the cobas 6800 system and 1,056 results for the cobas 8800 system in an eight-hour shift. Roche is committed to delivering as many tests as possible within the limits of supply.

The test is another key addition to the comprehensive Roche diagnostic portfolio to help healthcare providers combat COVID-19 and make informed decisions for optimized patient care. Currently, this portfolio includes molecular, serology and digital solutions, which help during the initial stages of infection, during the recovery phase, as well as following the resolution of infection.

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