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IMDX Monkeypox detection RT-PCR Assay by Siemens Healthineers has received manufacturing approval from the Central Drugs Standard Control Organization (CDSCO), confirmed a senior Health Ministry official on Tuesday.

IMDX Monkeypox detection RT-PCR Assay will be manufactured at the Company’s molecular diagnostics manufacturing unit in Vadodara, having a manufacturing capacity of 1 million reactions per annum. 

“The IMDX Monkeypox Detection RT-PCR Assay is a molecular diagnostic test that targets two distinct regions in the viral genome, spanning both clade I and clade II variants of the virus. This ensures thorough detection across various viral strains, providing comprehensive results. This assay is platform-agnostic and seamlessly fits into existing lab workflows with standard PCR setups, eliminating the need for new instruments. The ability to use existing COVID testing infrastructure would enhance the efficiency,’’ said Hariharan Subramanian, managing director, Siemens Healthcare, adding that the urgency for precise and accurate diagnostics couldn’t be more crucial now.

“By providing India with advanced assay kits tailored to combat Monkeypox, we are taking a proactive stance in battling this disease and prioritizing prompt and precise detection that can truly make a difference in saving lives,’’ he added. 

The Company noted that with results available in just 40 minutes, significantly faster than traditional methods (which take 1-2 hours), the assay helps reduce the turnaround time for reporting, leading to quicker responses.

Clinically validated by ICMR-National Institute of Virology, Pune, the assay boasts a 100% sensitivity and specificity. IMDX Monkeypox RTPCR Assay kits adhere to Indian statutory guidelines and comply with the highest global standards, said the Company.

The Union Health Ministry maintained that the approval for the kit was given last week. India has 32 labs equipped for testing mpox and the Ministry has noted that India is at moderate risk of getting the cases with sustained transmission.

Meanwhile, on 14 August the World Health Organisation classified the outbreak of Mpox as a global health emergency. A new strain of the disease has spread beyond the Democratic Republic of Congo for the first time, to at least 12 other African countries.

WHO has on Tuesday (August 27, 2024) in a release noted that it needs $ 87.4 million over 6 months, from September 2024 to February 2025, to work with countries, partners and other stakeholders to stop and contain the current outbreak of mpox.

“These funds will be used by WHO to implement critical activities outlined in the global strategic preparedness and response plan (SPRP) recently. The SPRP is a comprehensive framework developed by WHO to guide the global response to mpox, emphasizing surveillance, research, equitable access to medical countermeasures, and community empowerment. The required funds will be used across WHO headquarters, regional and country offices, to enable coordination of the response, provide technical assistance, run operations and deliver medical supplies,’’ said WHO.