Dive Brief:
- Roche said it is working with partners to increase laboratory capacity for mpox testing worldwide.
- The push to support diagnosis of mpox comes days after the World Health Organization declared an outbreak of the viral disease a public health emergency of international concern.
- A new strain of mpox is spreading rapidly in parts of the Democratic Republic of the Congo (DRC), the WHO said in a statement, and a coordinated international response is needed to stop outbreaks.
Dive Insight:
The new mpox strain, called clade 1b, is thought to be more virulent than the virus that reached the U.S. in 2022. The outbreak began in the DRC in September 2023.
The new strain has now spread to neighboring countries, with Burundi, Kenya, Rwanda and Uganda reporting their first cases, and the virus has begun to take hold in settings such as households, the WHO said. The health body said DRC has expanded access to lab testing.
The situation led the WHO and Africa Centres for Disease Control and Prevention to declare public health emergencies. Organizations including the Food and Drug Administration and the Centers for Disease Control and Prevention in the U.S. have set out their responses to the emergency.
Roche said it is partnering with governments, healthcare providers and organizations dedicated to combating the mpox outbreak. The company provides training for labs in Africa from its campus in South Africa and locally.
Roche was one of the first companies to receive emergency use authorization for an mpox test in the U.S. The FDA cleared a test for use on Roche’s Cobas 6800/8800 systems in November 2022. Abbott, Labcorp, Quest Diagnostics and others have authorized mpox products too. Roche has also developed PCR mpox assays that run on its Lightcycler 480 II instrument, Lightcycler PRO and Cobas z 480 analyzer.
The CDC said the government began working to prepare the U.S. for mpox, specifically the form spreading in the DRC, in December. There are no known cases of clade 1 mpox in the U.S., and the risk to most Americans is very low, the CDC said.
The CDC said the U.S. is well prepared to rapidly detect, contain and manage clade 1 cases “should they occur domestically.”