The rising cases of mpox globally have sparked concerns in India, with countries such as Africa, Thailand, Pakistan, and the Philippines being severely affected. On August 14, the World Health Organization (WHO) declared mpox a global public health emergency. The new strain of the virus, Clade I, is known to be more transmissible and has higher mortality rates. In response, India has developed an Indigenous RT-PCR testing kit to combat mpox, which has recently been approved by the Central Drugs Standard Control Organisation (CDSCO).
The IMDX Monkeypox Detection RT-PCR Assay, developed by Siemens Healthineers, has received manufacturing approval from the CDSCO. This marks a significant milestone for the "Make in India" initiative and represents a critical advancement in addressing the global mpox public health emergency. "The IMDX Monkeypox Detection RT-PCR Assay will be manufactured at our molecular diagnostics facility in Vadodara, which has a capacity of producing one million reactions per year. The factory is ready to make the kits available," stated Siemens Healthcare Private Ltd.
The assay is a pioneering molecular diagnostic test designed to target two distinct regions of the viral genome, covering both Clade I and Clade II variants. This ensures comprehensive detection across various viral strains, providing accurate and thorough results. Notably, this assay is platform-agnostic, allowing it to integrate seamlessly into existing laboratory workflows with standard PCR setups, eliminating the need for new instruments. Leveraging existing COVID-19 testing infrastructure will further enhance efficiency, Siemens noted.
Hariharan Subramanian, Managing Director of Siemens Healthcare Private Limited, emphasized the urgency for precise diagnostics in the current situation. "By equipping India with advanced assay kits specifically designed to detect mpox, we are taking a proactive stance in combating this disease and prioritizing rapid and accurate detection that can significantly impact saving lives. These kits reflect our commitment to improving 'Access to Care,' representing a significant step toward achieving that goal," he said.
Siemens Healthcare Private Ltd also highlighted that the test results from the IMDX Monkeypox Detection RT-PCR Assay would be available in just 40 minutes, significantly faster than traditional methods that typically take one to two hours. Clinically validated by the ICMR-National Institute of Virology in Pune, the assay demonstrates 100 per cent sensitivity and specificity. The IMDX Monkeypox RT-PCR Assay kits comply with Indian statutory guidelines and adhere to the highest global standards.
In preparation for a potential outbreak, the Karnataka government has announced the establishment of an isolation ward for any suspected or confirmed mpox cases. Dr Muzamil Sultan Koka, Senior Registrar at the Department of Critical Care Medicine, Marengo Asia Hospitals in Gurugram, noted that while mpox was once considered a rare disease, recent outbreaks have highlighted the need for increased awareness and preparedness.
As a zoonotic disease, mpox is transmitted from animals to humans and is caused by a virus related to the variola virus responsible for smallpox. Both viruses belong to the Orthopoxvirus genus.
Dr Koka also mentioned that the new strain, Clade 1b, has drawn attention due to its significantly different genetic composition from existing strains. "Although the behaviour of this new clade is still unknown, it is crucial to consider how the Indian population might respond to this potential threat," he stated.