The Central Drugs Standard Control Organization recently granted Siemens Healthcare permission to produce RT-PCR testing kits for Mpox detection, according to a senior Health Ministry official. The company’s molecular diagnostics unit in Vadodara will handle manufacturing, with an annual production capacity of one million tests.

These RT-PCR kits will deliver results within 40 minutes, significantly reducing the time compared to traditional methods that take one to two hours. This faster turnaround will lead to quicker reporting and responses, the company stated.

“The IMDX monkeypox detection RT-PCR assay is a molecular diagnostic test designed to target two specific regions in the viral genome, effectively covering both clade I and clade II variants. This wide-ranging detection ensures thorough results across various viral strains. The assay is compatible with existing lab workflows and standard PCR setups, eliminating the need for new equipment. Leveraging current COVID testing infrastructure will further boost efficiency,” stated Hariharan Subramanian, Managing Director of Siemens Healthcare.

He highlighted the urgent need for precise diagnostics in the current scenario. “By providing India with advanced assay kits tailored to combat Mpox, we are taking proactive steps to address this disease, focusing on prompt and accurate detection that can save lives,” Subramanian added. The Indian Council of Medical Research-National Institute of Virology in Pune has clinically validated the assay, demonstrating 100% sensitivity and specificity. The RT-PCR kits comply with Indian statutory guidelines and meet the highest global standards, according to the company.

The Union Health Ministry confirmed that approval for the kit was granted last week. Presently, India has 32 laboratories equipped for Mpox testing. Earlier, the Ministry indicated that India faces a moderate risk of Mpox cases with ongoing transmission. On August 14, the WHO declared the Mpox outbreak a global health emergency. A new strain of the virus has spread beyond the Democratic Republic of the Congo to at least 12 other African nations.

In a statement released on August 27, 2024, the WHO announced that it requires $87.4 million from September 2024 to February 2025 to work with countries, partners, and stakeholders to control the ongoing Mpox outbreak. “These funds will enable WHO to implement key activities outlined in the global strategic preparedness and response plan (SPRP),” the statement read.

The SPRP, recently developed by WHO , is a comprehensive framework guiding the global response to Mpox, focusing on surveillance, research, equitable access to medical countermeasures, and community empowerment. The required funds will be allocated across WHO headquarters, regional, and country offices to coordinate the response, provide technical assistance, run operations, and deliver medical supplies,” the statement said.