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Roche launches cobas 5800, a new molecular diagnostics system to expand access to testing and improve patient care

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Roche has launched the cobas 5800 System, a new molecular laboratory instrument that enhances diagnostic capabilities for infectious diseases. This compact system offers efficiency and timely results, addressing the growing medical needs of patients worldwide. Designed for laboratories of all sizes, it automates the workflow for maximum productivity, providing up to 144 results in an eight-hour shift. Roche anticipates FDA approval in Q3 2022, which could further enhance its market presence.

Positive
  • Launch of the cobas 5800 System enhances Roche's diagnostic capabilities.
  • The system delivers up to 144 results in an eight-hour shift, increasing lab efficiency.
  • Anticipated FDA approval in Q3 2022 may boost market access.
Negative
  • None.
  • Infectious diseases, such as those infections transmitted via respiratory, sexually and transplant, are becoming increasingly difficult to manage and represent an ever-growing medical need for millions of patients worldwide.
  • Access to accurate and reliable diagnostic tests help clinicians improve patient care, limit healthcare spending and contribute to protecting public health.
  • The cobas 5800 System is a compact new addition to the Roche Molecular portfolio, providing efficiency, simplicity and timely results to laboratories of all sizes so clinicians can quickly determine the best treatment strategies for their patients.

Basel, 18 November 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the cobas® 5800 System, a new molecular laboratory instrument, in countries accepting the CE mark. Testing is one of the first lines of defense to protect a patient’s general well-being and is vitally important in quickly guiding their treatment. The cobas 5800 System helps address challenges that laboratories are facing from an increase in patient testing, reimbursement complexities and the need for a more diverse testing menu while providing meaningful and timely results.  

“Diagnostics continue to revolutionise how providers care for patients, and it is essential, now more than ever, that the healthcare community has access to reliable and accurate testing solutions,” said Thomas Schinecker, CEO Roche Diagnostics. ”We are pleased that we can now offer a compact, fully-automated molecular system such as the cobas 5800 System. This new system helps to address the high demands on labs through greater efficiency, optimised workflows and cost savings, enabling them to deliver quality patient care.” 

The cobas 5800 system, the newest member of the Roche Molecular Work Area, is built upon the innovation of the cobas® 6800 and cobas® 8800 systems, making molecular testing accessible to more patients around the world.

Roche anticipates receiving U.S. Food and Drug Administration approval during Q3 2022.

About the cobas 5800 System
The cobas 5800 System is a real-time PCR molecular testing solution that provides excellent performance and value-added utility from a compact footprint. The cobas 5800 System delivers automation, consolidation, integration and standardisation – making it a scalable, cost-efficient solution for smaller labs seeking big lab performance, or for bigger labs seeking small lab agility.

The system is built to offer a fully automated workflow that encompasses sample supply, transfer and preparation, amplification and detection, result calculation and delivery to the laboratory information system (LIS). The single module enables a walkaway time of up to eight hours*, resulting in less hands-on time, which can lead to improved productivity, reduced possibility for errors and more predictable turnaround times.

The cobas 5800 System will offer the same menu as the cobas 6800 and 8800 Systems, including the cobas® SARS-CoV-2 test. The system offers an expanded on board capacity allowing labs to test multiple assays simultaneously and delivers up to 144 results in an eight-hour shift. This streamlined molecular testing system will allow most labs to consolidate greater than 90 percent** of their routine molecular tests onto a single platform. For more information please visit diagnostics.roche.com.

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics, as well as growing capabilities in the area of data-driven medical insights help Roche deliver truly personalised healthcare. Roche is working with partners across the healthcare sector to provide the best care for each person.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. In recent years, the company has invested in genomic profiling and real-world data partnerships and has become an industry-leading partner for medical insights.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the thirteenth consecutive year, Roche has been recognised as one of the most sustainable companies in the pharmaceutical industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. 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.

*Walkaway time is dependent on the number of tests performed and number of runs initiated (under continuous testing conditions >96 tests per shift, walkaway time may be between 4 - 8 hours).
**May vary based on assay availability in your country.

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

Dr. Nicolas Dunant
Phone: +41 61 687 05 17
Sileia Urech
Phone: +41 79 935 81 48

 
Dr. Barbara von Schnurbein
Phone: +41 61 687 89 67
Karsten Kleine
Phone: +41 61 682 28 31

 
Nina Mählitz
Phone: +41 79 327 54 74
Nathalie Meetz
Phone: +41 61 687 43 05

 

Roche Investor Relations

Dr. Karl Mahler
Phone: +41 61 68-78503
e-mail: karl.mahler@roche.com
Jon Kaspar Bayard
Phone: +41 61 68-83894
e-mail: jon_kaspar.bayard@roche.com
Dr. Sabine Borngräber
Phone: +41 61 68-88027
e-mail: sabine.borngraeber@roche.com
Dr. Bruno Eschli
Phone: +41 61 68-75284
e-mail: bruno.eschli@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
 

 

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FAQ

What is the cobas 5800 System launched by Roche?

The cobas 5800 System is a new molecular laboratory instrument designed to improve diagnostic efficiency for infectious diseases.

When does Roche expect FDA approval for the cobas 5800 System?

Roche anticipates receiving FDA approval for the cobas 5800 System in Q3 2022.

How many results can the cobas 5800 System process in an eight-hour shift?

The cobas 5800 System can deliver up to 144 results in an eight-hour shift.

What are the benefits of the cobas 5800 System?

The cobas 5800 System offers efficiency, automated workflows, and timely diagnostics for healthcare providers.

What medical needs does the cobas 5800 System address?

It addresses the growing challenges of managing infectious diseases and improves patient care through reliable diagnostics.

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