Roche receives FDA EUA for cobas SARS-CoV-2 Duo, the first PCR test to simultaneously detect COVID-19 and quantitatively measure viral load levels of COVID-19
Roche has received Emergency Use Authorization (EUA) from the FDA for its cobas SARS-CoV-2 Duo test, a groundbreaking automated RT-PCR assay. This test provides both qualitative and quantitative results, enabling precise measurement of the viral load in COVID-19 patients. The test aims to enhance patient management by improving contact tracing and medical intervention strategies. By linking quantitative results to WHO standards, it facilitates consistent patient assessment across healthcare settings. The test will be available in the U.S. by Q2 2022.
- FDA Emergency Use Authorization for cobas SARS-CoV-2 Duo test enhances Roche's portfolio.
- First automated RT-PCR assay for both qualitative and quantitative detection of SARS-CoV-2.
- Quantitative results aid in better patient management and clinical assessment.
- None.
- 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.
About the cobas SARS-CoV-2 Duo test
The cobas SARS-CoV-2 Duo test received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) on June 14, 2022. The cobas SARS-CoV-2 Duo for use on the cobas® 6800/8800 Systems is an automated real-time RT-PCR assay for the qualitative detection of SARS-CoV-2 RNA in healthcare provider instructed self-collected nasal swab specimens (collected on site), and healthcare provider-collected nasal and nasopharyngeal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider. This assay also performs quantitation of SARS-CoV-2 RNA levels in the collected specimen; however, only the qualitative result of cobas® SARS-CoV-2 Duo is intended for use as an aid in the diagnosis of SARS-CoV-2 infection in patients suspected of COVID-19 by their healthcare provider.
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
In recognizing our endeavor to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.
Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
For more information, please visit www.roche.com.
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