Roche Joins Fight Against Mpox Outbreak with High-Quality PCR Diagnostic Tests

Mpox, formerly known as monkeypox, is a viral disease that can spread easily between people and from infected animals. The mpox virus 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. Mpox was declared a Public Health Emergency of International Concern by the World Health Organization (WHO) on August 14, 2024.

Roche (Basel, Switzerland) has announced that it is supporting the international response to the mpox global health emergency with its diagnostic tests developed for mpox. Roche is partnering with governments, healthcare providers, and organizations across the world that are dedicated to combating the mpox outbreak. The company is actively working with its partners to enhance mpox laboratory capacity globally. Additionally, Roche provides training for laboratories across the African continent at the Roche Scientific Campus in South Africa, as well as locally.

To detect the mpox virus, Roche has 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. 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.

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. The cobas MPXV test is meant for use on the high-throughput cobas 6800/8800 Systems.

“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.”

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