Roche expands COVID-19 PCR test portfolio to new cobas 5800 system in CE Member States |
Roche expands COVID-19 PCR test portfolio to new cobas 5800 system in CE Member States |

Roche expands COVID-19 PCR test portfolio to new cobas 5800 system in CE Member States |

Roche continues to increase access to accurate, timely and reliable diagnostics in the fight against COVID-19 by expanding the COVID-19 PCR portfolio on the cobas 5800 system

These tests are for qualitative detection of SARS-CoV-2 and qualitative detection and differentiation of SARS-CoV-2, influenza A virus and / or influenza B virus

As communities around the globe still need effective solutions for COVID-19, Roche will continue to invest in diagnostics to ensure that testing opportunities are available to healthcare communities and patients worldwide.

PLEASANTON, California, February 23, 2022 / PRNewswire / – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the expansion of the COVID-19 PCR portfolio to cobas 5800 System, a recent launched molecular laboratory instrument, in countries that accept the CE mark. These include cobas SARS-CoV-2 qualitative and cobas SARS-CoV-2 & Influenza A / B tests. These launches expand Roche Diagnostics’ molecular portfolio offering by delivering standardized performance and efficiency across needs for low-, medium-, and high-volume molecular laboratory testing. In addition, the new compact cobas 5800 System expands access to healthcare systems with limited resources or space. This means better access to testing in countries or environments where there is not enough space or resources to accommodate larger instruments.

“Roche offers a comprehensive portfolio of tests for infectious diseases along the continuum of care, enabling laboratories to provide the right information from screening to diagnosis, to patient management and treatment monitoring,” he said. Cindy Perettie, Head of Molecular Labs Customer Area, Roche Diagnostics. “Patients are at the heart of our diagnostic solutions and we are pleased to be able to increase access to accurate, timely and reliable diagnostics with our COVID-19 portfolio on the cobas 5800 system to meet changing testing requirements.”

The COVID-19 portfolio adds to the menu for infectious diseases – HIV-1, HBV, HCV, HIV-1 / HIV-2 Qualitative – and the cobas omni Utility Channel for use on the cobas 5800 system in countries that accept the CE mark launched in December 2021. The cobas 5800 system will offer the same menu as the cobas 6800 and 8800 systems. Roche is pursuing CE approval for continued menu expansion on the cobas 5800 system until early to mid-2022. Roche expects tests to be available outside the CE markets in additional countries by 2022.

About the tests

SARS-CoV-2: cobas SARS-CoV-2 Qualitative is intended for the qualitative detection of SARS-CoV-2. The test supports nasal, nasopharyngeal and oropharyngeal grafts and saliva samples. SARS-CoV-2, influenza A, influenza B: cobas SARS-CoV-2 & Influenza A / B are intended for simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus and / or influenza B virus RNA in nasal and nasopharyngeal grafts.

About the cobas 5800 system

The cobas 5800 system, a compact new addition to the Roche Diagnostics Molecular Work Area, is built on the innovation of the cobas 6800 and 8800 systems, making molecular testing available to more patients worldwide.

The cobas 5800 system is a real-time PCR molecular test solution that delivers excellent performance and added value from a compact footprint. The cobas 5800 system provides automation, consolidation, integration and standardization – making it a scalable, cost-effective solution for smaller laboratories seeking high laboratory performance, or for larger laboratories seeking flexibility in small laboratories.

The system is built to offer a fully automated workflow that includes sample supply, transfer and preparation, amplification and detection, result calculation and delivery to the Laboratory Information System (LIS). The individual module enables a running time of at least 4 hours *, which results in less practical time, which can lead to improved productivity, reduced possibility of errors and more predictable processing times. The cobas 5800 system offers an extended built-in capability that allows laboratories to test multiple assays simultaneously and deliver up to 144 results in an eight-hour shift. This streamlined molecular testing system will allow most laboratories to consolidate more than 90 percent ** of their routine molecular testing on a single platform.

* Selection time depends on the number of tests performed and the number of runs started (under continuous test conditions> 96 tests per shift, the running time can be between 4 – 8 hours).

** May vary depending on analysis availability in your country.

About Roche

Roche is a global pioneer in medicine and diagnostics with a focus on advancing science to improve human lives. The combined strengths of drugs and diagnostics as well as growing capabilities in data-driven medical insight help Roche deliver true personalized healthcare. Roche works 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 medicine in the fields of oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also a world leader in in vitro diagnostics and tissue-based cancer diagnostics and a frontrunner in diabetes care. In recent years, Roche has invested in real-world genomic profiling and data partnerships and has become an industry-leading medical insight partner.

Roche was founded in 1896 and 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 patients’ 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 drugs, including life-saving antibiotics, antimalarial drugs and cancer drugs. In addition, for the twelfth year in a row, Roche has been recognized as one of the most sustainable companies in the pharmaceutical industry by the Dow Jones Sustainability Indices (DJSI).

Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and by 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and book sales of CHF 58.3 billion. Genentech, i The United States, is a wholly owned member of the Roche Group. Roche is a majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

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Media contacts:

Elizabeth Baxter

[email protected]

+1,925,523,8812

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