Siemens Healthineers gets drug regulator’s nod to make Mpox test kits
India’s drug regulator has given Siemens Healthineers the approval to make the Mpox test kit, which will boost the country’s efforts to detect and treat the disease.
India’s drug regulator has given approval to Siemens Healthineers to manufacture test kits for Mpox.
After the World Health Organisation (WHO) declared ampox (earlier called monkeypox) a global health concern, India has ramped up facilities for detection, surveillance and treatment of ampox.
The Central Drugs Standard Control Organisation (CDSCO) has granted manufacturing approval to the company to make RT-PCR kits for detecting Pox in people.
According to news agency ANI, Siemens Healthcare Pvt Ltd said, “The IMDx Monkeypox Detection RT-PCR assay will be manufactured at our molecular diagnostics manufacturing unit in Vadodara, which has a manufacturing capacity of 1 million reactions per year. The factory is fully ready to make the kits available.”
The company said the test will target two distinct regions in the viral genome, targeting both clade I and clade II variants of the virus.
“This ensures in-depth testing across different viral strains, delivering comprehensive results. Notably, this assay is platform-agnostic and seamlessly fits into existing lab workflows with standard PCR setups, eliminating the need for new equipment. The ability to utilise existing COVID testing infrastructure will enhance efficiency,” he added.
The Indian Council of Medical Research-National Institute of Virology, Pune has clinically validated this test, claiming 100% sensitivity and specificity.
The company said the RT-PCR kits adhere to Indian statutory guidelines and comply with the highest global standards.
Earlier in August, the World Health Organisation classified the ampox outbreak as a global health emergency after a new variant of the virus spread beyond the Democratic Republic of Congo to at least 12 other African countries for the first time.
By then the disease had spread to 116 countries.
Ampox, formerly known as monkeypox, is a viral infection similar to smallpox but is generally less severe. It is caused by the monkeypox virus, which belongs to the same family as the variola virus, which causes smallpox.
Ampox is spread by close contact with an infected person or animal or by touching contaminated materials. Symptoms include fever, headache, muscle aches, and a rash that often begins on the face and then spreads to other parts of the body.
The rash gradually turns into pus-filled lesions that eventually crust over and heal. While most cases are mild, severe cases can occur, especially in individuals with weakened immune systems.
The health agency has launched a plan to prevent outbreaks through human-to-human transmission of the disease between September 2024 and February 2025, the WHO said in a statement.
