India develops first indigenous Mpox RT-PCR detection kit, gets CDSCO approval

The rise in mpox cases across the world has raised concerns in India, where countries including Africa, Thailand, Pakistan and the Philippines have been 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 test kit to combat mpox, which has recently been approved by the Central Drugs Standard Control Organization (CDSCO).

The IMDX Monkeypox The RT-PCR detection 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 step forward in addressing the global public health emergency of mpox. “IMDX’s monkeypox RT-PCR detection assay will be manufactured at our molecular diagnostics facility in Vadodara, which has a capacity to produce one million reactions per year. The factory is ready to make the kits available,” said Siemens Healthcare Private Ltd.

The assay is a pioneering molecular diagnostic test designed to target two distinct regions of the viral genome, spanning clade I and clade II variants. This ensures comprehensive detection across multiple viral strains, providing accurate and comprehensive results. Notably, this assay is platform-agnostic, allowing it to be seamlessly integrated into existing laboratory workflows with standard PCR setups, eliminating the need for new instruments. Leveraging existing COVID-19 testing infrastructure will further improve efficiency, Siemens noted.

Hariharan Subramanian, Managing Director, Siemens Healthcare Private Limited, stressed the urgency of accurate diagnostics in the current situation. “By equipping India with advanced testing kits specifically designed to detect mpox, we are taking a proactive stance in the fight against this disease and prioritising rapid and accurate detection that can have a significant impact on saving lives. These kits reflect our commitment to improving ‘Access to Care’, which represents a significant step towards achieving that goal,” he said.

Siemens Healthcare Private Ltd also highlighted that the results of the IMDX Monkeypox RT-PCR test would be available in just 40 minutes, significantly faster than traditional methods that typically take one to two hours. The assay, clinically validated by ICMR-National Institute of Virology in Pune, demonstrates 100 percent sensitivity and specificity. The IMDX Monkeypox RT-PCR kits comply with Indian legal guidelines and adhere to the highest global standards.

In preparation for a possible outbreak, the Karnataka government has announced the establishment of an isolation ward for any suspected or confirmed case of mpox. Dr Muzamil Sultan Koka, a senior physician at the Department of Critical Care Medicine at Marengo Asia Hospitals in Gurugram, said that while mpox was once considered a rare disease, recent outbreaks have highlighted the need for greater awareness and preparedness.

MPOX is a zoonotic disease 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 attracted attention due to its significantly different genetic makeup from existing strains. “While 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 said.