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

  • Infectious diseases, such as respiratory, sexually transmitted and transplant-transmitted infections, are becoming increasingly difficult to manage and represent an ever-growing medical need for millions of patients around the world.

  • Access to accurate and reliable diagnostic tests helps clinicians improve patient care, limit healthcare costs, and help protect public health.

  • The cobas The 5800 system is a new compact addition to the Roche Molecular range, delivering efficiency, simplicity and rapid results to laboratories of all sizes so clinicians can quickly determine the best treatment strategies for their patients.

Basel, November 18, 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the cobas® 5800 System, a new molecular laboratory instrument, in countries accepting CE marking. Testing is one of the first lines of defense in protecting a patient’s general well-being and is vitally important in guiding treatment quickly. The cobas 5800 system helps meet the challenges laboratories face with increasing patient testing, reimbursement complexities, and the need for a more diverse test menu while delivering meaningful and timely results.

“Diagnostics continue to revolutionize the way providers care for patients, and it is more critical than ever that the healthcare community has access to reliable and accurate testing solutions,” said Thomas Schinecker, CEO of Roche Diagnostics. “We are delighted that we can now offer a compact, fully automated molecular system such as the cobas 5800 system. This new system helps meet the high demands of laboratories through greater efficiency, improved workflows and cost savings. , enabling them to provide quality patient care.

The cobas 5800 system, the newest member of the Roche Molecular Work Area, is based on the innovation of cobas® 6800 and cobas® 8,800 systems, making molecular testing accessible to more patients around the world.

Roche expects to receive approval from the U.S. Food and Drug Administration in the third quarter of 2022.

About cobas System 5800
The cobas 5800 System is a real-time molecular PCR test solution that delivers excellent performance and value-added utility from a compact footprint. The cobas 5800 system provides automation, consolidation, integration and standardization, making it a scalable and cost-effective solution for small laboratories looking for large laboratory performance or for large laboratories looking for a little laboratory agility.

The system is designed to provide a fully automated workflow that encompasses procurement, sample transfer and preparation, amplification and detection, calculation of results and delivery to the Laboratory Information System (LIS) . Unique module allows for up to eight hours of downtime *, reducing response time, which can lead to improved productivity, reduced possibility of 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 extensive on-board capability allowing laboratories to test multiple assays simultaneously and delivers up to 144 results in eight hours. This streamlined molecular testing system will allow most laboratories to consolidate over 90% ** of their routine molecular testing on a single platform. For more information, visit

About Roche
Roche is a global pharmaceutical and diagnostics pioneer focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics, along with growing capabilities in data-driven medical knowledge, help Roche deliver truly personalized healthcare. Roche works with partners in the healthcare industry to provide the best care for every person.

Roche is the world’s largest biotechnology company, with truly differentiated drugs in oncology, immunology, infectious diseases, ophthalmology and central nervous system diseases. Roche is also the world leader in in vitro diagnostics and tissue diagnostics for cancer, and a pioneer in the management of diabetes. Over the past few years, the company has invested in genomic profiling and real-world data partnerships and has become an industry leading partner for medical knowledge.

Founded in 1896, Roche continues to research better ways to prevent, diagnose and treat disease and make a lasting contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty drugs developed by Roche are included in the World Health Organization’s Model Lists of Essential Medicines, including life-saving antibiotics, antimalarials and cancer drugs. In addition, for the thirteenth consecutive year, Roche has been recognized 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 more than 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and achieved sales of CHF 58.3 billion. Genentech, in the United States, is a full member of the Roche group. Roche is the majority shareholder of Chugai Pharmaceutical, in Japan. For more information, please visit

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

* The running time depends on the number of tests performed and the number of analyzes initiated (under continuous test conditions> 96 tests per shift, the running time can be between 4 and 8 hours).
** May vary depending on availability of tests in your country.

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