Roche is committed to supporting all those working to overcome the mpox outbreak by providing access to high-quality Polymerase Chain Reaction (PCR) testing
Roche confirms that its cobas MPXV test, as well as the LightMix® research use only kits, detect the latest mpox virus variants
It is actively working to enhance laboratory testing capacity for mpox worldwide
Basel, 20 August 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it is supporting the international response to the mpox global health emergency with its diagnostic tests developed for mpox, formerly known as monkeypox. Mpox, a viral disease that can spread easily between people and from infected animals, was declared a Public Health Emergency of International Concern by the World Health Organization (WHO) (14 August 2024).
Globally, Roche is partnering with governments, healthcare providers and organisations dedicated to combating the mpox outbreak. More specifically, Roche is actively working with its partners to enhance mpox laboratory capacity worldwide. In addition, Roche provides training for laboratories across the African continent at the Roche Scientific Campus in South Africa, as well as locally.
“Our commitment to support the global response to mpox began in 2022 when we developed a suite of tests to enable global access to rapid and high-quality PCR testing,” said Matt Sause, CEO of Roche Diagnostics. “Diagnostics are essential in addressing emerging public health challenges like mpox, as they enable healthcare providers to identify infected patients, devise effective treatment strategies and take appropriate actions.”
To detect the mpox virus, Roche developed three unique LightMix® Modular Virus kits* for use on either a LightCycler®480 II Instrument*, LightCycler® PRO or cobas® z 480 Analyzer, as well as the cobas® MPXV test for use on the cobas® 6800/8800 Systems.
About the LightMix Modular Orthopox / MonkeypoxVirus Kits
In May 2022, Roche and its subsidiary TIB Molbiol rapidly developed a new suite of tests that detect the virus that causes mpox and aid in following its epidemiologic spread. The LightMix Modular Orthopox / Monkeypox Virus Kits are assays that detect Orthopoxviruses, including the virus that causes mpox, using a technology called quantitative PCR (qPCR). To do this, the test is performed with a patient sample that is first extracted using an established nucleic acid (NA) extraction method. The assay is then performed on either a LightCycler®480 II Instrument*, LightCycler® PRO or cobas® z 480 Analyzer.
The LightMix Modular Orthopox / Monkeypox Virus kits are intended for use in confirmatory testing (evaluation and validation) in public health labs as Research Use Only, and are designed for research use in the majority of countries worldwide.
About the cobas MPXV test
In November 2022, the FDA granted Roche Emergency Use authorization (EUA) for the cobas MPXV test for use on the high-throughput cobas 6800/8800 Systems. The cobas MPXV test is an automated, real-time PCR test for the qualitative detection of DNA from the virus (MPXV) that causes mpox in human lesion swabs collected from individuals suspected of mpox infection by their healthcare provider and uses a dual-target approach. This approach ensures that cobas MPXV will continue to detect the virus even if a mutation occurs in one target region.
About the virus
MPXV was first detected in laboratory monkeys in 1958. The virus is, however, assumed to be transmitted from wild animals such as rodents to people — or from human to human. Symptoms of mpox include fever, chills, headaches, muscle aches, fatigue, swollen lymph nodes and a painful rash that characteristically appears as raised bumps on the skin and tends to be distributed on the face, extremities and genitals. As the disease progresses, these bumps fill with pus and fluid and become umbilicated. They will eventually ulcerate, scab and fall off.
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 under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
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.
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 twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals 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