The cobas® SARS-CoV-2 Duo test combines the standard qualitative result of a traditional SARS-CoV-2 PCR test with a quantitative result, which measures the viral load of a patient suspected of COVID-19.
Potential benefits of the cobas® SARS-CoV-2 Duo test aim to help the healthcare community with contact tracing, patient triage and the approach to medical care.
Since the start of pandemic, Roche has focused on bringing effective diagnostic solutions to healthcare communities worldwide in the fight against COVID-19
Basel, 15 June 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) 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 is 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.
With the SARS-CoV-2 Duo test, we are now able to detect the COVID-19 virus and simultaneously measure the viral load in an individual,
said Thomas Schinecker, CEO Roche Diagnostics.
The test’s performance suggests that, by earlier and more accurately identifying infected patients, the results may open the path for healthcare providers to more efficiently organise their therapeutic and monitoring interventions.
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.