1. Homepage
  2. Equities
  3. Switzerland
  4. Swiss Exchange
  5. Roche Holding AG
  6. News
  7. Summary
    ROG   CH0012032048


Delayed Swiss Exchange  -  11:30 2022-08-16 am EDT
315.65 CHF   -0.71%
06:43aGenentech - FDA Accepts Supplemental Biologics License Application for Genentech's Polivy Combination for People with Previously Untreated Diffuse Large B-Cell Lymphoma
01:21aSwiss Drugmaker Roche Gets US FDA Review for Lymphoma Treatment
01:02aFDA Accepts Supplemental Biologics License Application for Genentech's Polivy Combination for People With Previously Untreated Diffuse Large B-Cell Lymphoma
SummaryMost relevantAll NewsAnalyst Reco.Other languagesPress ReleasesOfficial PublicationsSector newsMarketScreener Strategies

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

06/15/2022 | 11:45am EDT
  • 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 2022Roche (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.

All trademarks used or mentioned in this release are protected by law.

Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD
Phone: +41 61 687 41 47
Karsten Kleine
Phone: +41 61 682 28 31

Nina Mählitz
Phone: +41 79 327 54 74
Nathalie Meetz
Phone: +41 79 771 05 25

Dr. Barbara von Schnurbein
Phone: +41 61 687 89 67
Sileia Urech
Phone: +41 79 935 81 48


Roche Investor Relations

Dr. Bruno Eschli
Phone: +41 61 68-75284
e-mail: bruno.eschli@roche.com
Dr. Sabine Borngräber
Phone: +41 61 68-88027
e-mail: sabine.borngraeber@roche.com

Dr. Birgit Masjost
Phone: +41 61 68-84814
e-mail: birgit.masjost@roche.com
Dr. Gerard Tobin
Phone: +41 61 68-72942
e-mail: gerard.tobin@roche.com

Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com



  • 06152022_MR_cobas SARS-CoV-2 Duo_en

© OMX, source GlobeNewswire - EU Press Releases

All news about ROCHE HOLDING AG
06:43aGenentech - FDA Accepts Supplemental Biologics License Application for Genentech's Poli..
01:21aSwiss Drugmaker Roche Gets US FDA Review for Lymphoma Treatment
01:02aFDA Accepts Supplemental Biologics License Application for Genentech's Polivy Combinati..
01:01aFDA accepts supplemental Biologics License Application for Roche's Polivy combination f..
08/15Novartis fails again to reuse anti-inflammatory drug to treat lung cancer
08/15Roche Unveils New Diagnostic Test for COVID-19 Immune Response
08/15Roche launches new diagnostic test for the better understanding of immune response to S..
08/15Roche Launches New Diagnostic Test for the Better Understanding of Immune Response to S..
08/14Switzerland Negotiating Pharmaceutical Trade Deal With US
08/13U.S. and Switzerland working on facilitating pharma trade - U.S. ambassador
More news
Analyst Recommendations on ROCHE HOLDING AG
More recommendations
Sales 2022 64 249 M 67 599 M 67 599 M
Net income 2022 14 824 M 15 597 M 15 597 M
Net Debt 2022 10 272 M 10 807 M 10 807 M
P/E ratio 2022 17,1x
Yield 2022 3,04%
Capitalization 262 B 276 B 276 B
EV / Sales 2022 4,24x
EV / Sales 2023 4,12x
Nbr of Employees 100 920
Free-Float 82,4%
Duration : Period :
Roche Holding AG Technical Analysis Chart | MarketScreener
Full-screen chart
Technical analysis trends ROCHE HOLDING AG
Short TermMid-TermLong Term
Income Statement Evolution
Mean consensus OUTPERFORM
Number of Analysts 25
Last Close Price 317,90 CHF
Average target price 374,13 CHF
Spread / Average Target 17,7%
EPS Revisions
Managers and Directors
Severin Schwan Chief Executive Officer & Executive Director
Alan Hippe Chief Financial & Information Officer
Christoph Franz Chairman
Levi A. Garraway Chief Medical Officer
Pascale Schmidt Chief Compliance Officer
Sector and Competitors
1st jan.Capi. (M$)
ROCHE HOLDING AG-16.14%277 502
JOHNSON & JOHNSON-2.91%436 680
PFIZER, INC.-15.75%279 215
ABBVIE INC.5.09%251 582
NOVO NORDISK A/S5.65%241 077