Roche’s test for Covid-19 and influenza A/B receives FDA EUA

7 September 2020 (Last Updated September 7th, 2020 18:34)

The cobas SARS-CoV-2 & Influenza A/B Test developed by Roche for use on the cobas 6800/8800 Systems has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA).

The cobas SARS-CoV-2 & Influenza A/B Test developed by Roche for use on the cobas 6800/8800 Systems has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA).

Designed for the simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A and Influenza B virus, the test is a multiplex reverse transcription-polymerase chain reaction (RT-PCR) assay.

It can be used for detection of coronavirus and Influenza A/B virus in patients suspected of respiratory viral infection related to Covid-19 via nasal or nasopharyngeal swab samples.

Roche’s completely automated cobas 6800/8800 Systems are claimed to offer the quickest time to results with the highest throughput, besides the longest walk-away time available among molecular platforms that are automated.

The systems offer 96 results in approximately three hours, 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an eight-hour shift.

Roche Diagnostics CEO Thomas Schinecker said: “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.

“As a leader in diagnostics testing solutions, this launch demonstrates our ongoing commitment to stop the spread of serious infectious diseases by increasing access to accurate, reliable and efficient testing options.”

The SARS-CoV-2 & Influenza A/B Test is also available in markets, accepting the CE mark.

The test is the latest addition to Roche’s diagnostic portfolio for Covid-19. Previously, the company launched a new blood gas digital diagnostic tool, called Roche v-TAC, to simplify and accelerate the screening of patients with respiratory problems during the Covid-19 pandemic.

In May, the company rolled out Elecsys Anti-SARS-CoV-2 Covid-19 antibody test at more than 20 commercial and hospital lab sites across the US.