India has taken a significant leap in its battle against the global monkeypox outbreak with the launch of an indigenous RT-PCR testing kit. Developed by Siemens Healthineers, the IMDX Monkeypox Detection RT-PCR Assay has received approval from the Central Drugs Standard Control Organisation (CDSCO), marking a crucial achievement for the “Make in India” initiative and a vital asset in addressing the ongoing public health emergency.
The approval comes in the wake of the World Health Organization (WHO) declaring its second public health emergency of international concern due to the emergence of a new, highly transmissible, and lethal strain of the monkeypox virus, Clad-1.
Siemens’ new test kit is engineered to provide rapid and accurate detection of the virus, effectively identifying both clade I and clade II variants. With results available in just 40 minutes—significantly faster than the traditional one to two-hour timeframe—the assay represents a major advancement in diagnostic capabilities.
Hariharan Subramanian, Managing Director of Siemens Healthcare Private Limited, highlighted the critical role of timely diagnostics in managing the monkeypox crisis. “By equipping India with advanced assay kits designed specifically to tackle monkeypox, we are proactively contributing to the fight against this disease. Rapid and accurate detection is key to saving lives,” Subramanian remarked.
Manufactured at Siemens’ facility in Vadodara, the IMDX Monkeypox Detection RT-PCR Assay is set to produce up to one million reactions annually. The platform-agnostic design ensures seamless integration into existing laboratory workflows, leveraging the COVID-19 testing infrastructure to enhance efficiency and response times.
Clinically validated by the ICMR-National Institute of Virology in Pune, the assay boasts 100% sensitivity and specificity, meeting both Indian statutory guidelines and global standards. This development is expected to significantly bolster India’s efforts in controlling the spread of monkeypox and protecting public health.