On Jun. 14, 2022, Roche announced that the US Food and Drug Administration had issued Emergency Use Authorization (EUA) for the cobas SARS-CoV-2 Duo for use on the fully automated cobas 6800/8800 Systems, expanding the Roche COVID-19 portfolio. This was the first automated, real-time RT-PCR assay for the in vitro qualitative and quantitative detection of SARS-CoV-2 RNA in nasal and nasopharyngeal swab specimens.

The quantitative result is traceable to the World Health Organization (WHO) International Standard for SARS-CoV-2 RNA. The potential benefits from reporting a standardized viral load along with the qualitative result may help clinicians in the assessment and monitoring of infected patients across laboratories and over time.

Roche continues to add a range of diagnostic solutions to our global portfolio to help in the fight against COVID-19. For more information on how Roche is responding to the global COVID-19 pandemic, please visit our COVID-19 response page. The test will be available in the United States by Q2 2022.