Roche announced the expansion of the COVID-19 PCR portfolio to the cobasⓇ 5800 System, a recently launched molecular laboratory instrument, in countries accepting the CE mark. These include cobas SARS-CoV-2 Qualitative and cobas SARS-CoV-2 & Influenza A/B tests. These launches expand the Roche Diagnostics molecular portfolio offering by providing standardised performance and efficiencies across low, medium and high volume molecular laboratory testing needs. In addition, the new compact cobas 5800 System broadens access for healthcare systems with limited resources or space. This means better access to testing in countries or environments where there isn’t enough space or resources to accommodate larger instruments.
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“Roche offers a comprehensive portfolio of infectious disease tests along the continuum of care, enabling laboratories to provide the right information from screening to diagnosis, for patient management and treatment monitoring,” said Cindy Perettie, Head of the Molecular Lab Customer Area, Roche Diagnostics. “Patients are at the heart of our diagnostics solutions and we are pleased that we can increase access to accurate, timely and reliable diagnostics with our COVID-19 portfolio on the cobas 5800 System to meet evolving testing demands.”
The COVID-19 portfolio adds to the infectious diseases menu – HIV-1, HBV, HCV, HIV-1/HIV-2 Qualitative – and cobas omni Utility Channel for use on the cobas 5800 System in countries accepting 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, through early-to-mid 2022. Roche anticipates tests to be available beyond CE markets in additional countries in 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 swabs and saliva specimens. SARS-CoV-2, influenza A, influenza B: cobas SARS-CoV-2 & Influenza A/B is intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus RNA in nasal and nasopharyngeal swabs.
About the cobas 5800 System
The cobas 5800 System, a compact new addition to the Roche Diagnostics Molecular Work Area, is built upon the innovation of the cobas 6800 and 8800 Systems, making molecular testing accessible to more patients around the world.
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 laboratory performance, or for bigger laboratories seeking small lab agility.