Healthcare Industry News:  Roche Diagnostics 

Diagnostics Product Launch

 News Release - December 15, 2021

Roche Launches the First Infectious Disease Tests and Cobas Omni Utility Channel for Use on the Cobas 5800 System in Countries Accepting the CE Mark

Infectious diseases are a leading cause of death globally. Roche is committed to reducing the burden of infectious diseases through effective testing, monitoring and management.

These will be the first tests launched for use on the new cobas 5800 System to support patient management of human immunodeficiency virus, Hepatitis B and C virus.

In addition, the launch of the cobas omni Utility Channel enables laboratory professionals the flexibility of running CE-IVD assays, as well as designing their own laboratory developed tests (LDTs)

This new offering expands access to critical and robust diagnostic tools that enables healthcare providers to deliver high quality care to patients worldwide, including access to regions with the highest disease burdens.

PLEASANTON, Calif., Dec. 15, 2021 -- (Healthcare Sales & Marketing Network) -- Roche (SIX: RO, ROG;OTCQX: RHHBY) today announced the launch of the first infectious disease tests on the cobas® 5800 System, a new molecular laboratory instrument, in countries accepting the CE mark. These include cobas® HIV-1, cobas® HBV, cobas® HCV, cobas® HIV-1/HIV-2 Qualitative, and the cobas omni Utility Channel kit. These launches expand the Roche Molecular portfolio offering by providing standardised performance and efficiencies across low, medium and high volume molecular laboratory testing needs.

"Roche offers a comprehensive portfolio of infectious disease tests along the continuum of care, enabling laboratories to provide the right information, from screening and diagnosis, for patient management and treatment monitoring," said Cindy Perettie, Head of the Molecular Lab Customer Area, Roche Diagnostics. "We are pleased that we can increase access to accurate, timely and reliable diagnostics with our first tests on the cobas 5800 System to patients and their healthcare teams to meet evolving testing demands."

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 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, including cobas SARS-CoV-2, through early-to-mid 2022. Roche anticipates tests to be available beyond CE markets in additional countries in 2022.

About the cobas omni Utility Channel on the cobas 5800 System

The cobas omni Utility Channel on the cobas 5800 System enables a broader testing menu by consolidating open channel assays with Roche in vitro diagnostic (IVD) assays on a single platform. Open channel assays may include IVD assays, research testing, as well as routine lab developed tests (LDTs). The ability to consolidate and automate a wider array of testing on a single platform helps to increase operational efficiency, maximise laboratory space and minimise capital investment.

About the tests

HIV-1: cobas HIV-1 is built upon the dual-target assay design from Roche. The test simultaneously amplifies and detects two separate regions of the HIV-1 genome, which are not subject to selective drug pressure, allowing for more reliable results to confidently and effectively quantify the amount of HIV-1 RNA in a patient's blood.

HCV: cobas HCV employs Roche's unique dual-probe approach to provide an extra layer of protection against mutations that can occur in the viral genome and is designed to accurately detect and quantify hepatitis C virus ribonucleic acid (RNA) with state-of-the-art sensitivity in order to assess a patient's response to antiviral therapy.

HBV: cobas HBV is a real-time PCR test designed to offer an expanded linear range with two input volumes coupled with broad coverage of all known HBV genotypes (A-H), including pre-core mutations with high sensitivity.

HIV Diagnostics (HIV-1/HIV-2 Qual.): cobas HIV-1/HIV-2 Qualitative is an in vitro nucleic acid amplification test for the qualitative detection and differentiation of HIV-1 and HIV-2 in human serum, plasma, and Dried Blood Spots. The test is intended to be used as an aid in diagnosis of HIV-1/HIV-2.

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 laboratory performance, or for bigger laboratories 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 at least 4 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 offers an expanded on-board capacity allowing 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 labs to consolidate greater than 90 percent** of their routine molecular tests onto a single platform.

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*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.

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.

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

Source: Roche Group

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