National Desk, 27th August: In a significant breakthrough for India’s healthcare sector, Siemens Healthineers has successfully developed a home-grown RT-PCR testing kit for the detection of monkeypox, receiving approval from the Central Drugs Standard Control Organisation (CDSCO). This marks a vital step forward in the “Make in India” initiative, offering a powerful tool in the global fight against the escalating monkeypox outbreak.
The approval comes at a critical juncture as the World Health Organization (WHO) has declared its second public health emergency of international concern, driven by a more transmissible and deadly strain of the monkeypox virus, Clade 1. Siemens Healthineers’ IMDX Monkeypox Detection RT-PCR Assay is specifically designed to rapidly and accurately detect both Clade I and Clade II variants of the virus.
Hariharan Subramanian, Managing Director of Siemens Healthcare Private Limited, underscored the importance of swift diagnostics in curbing the spread of the disease. “By providing India with advanced assay kits tailored to combat monkeypox, we are taking a proactive stance in battling this disease. Prompt and precise detection can truly make a difference in saving lives,” Subramanian said.
Manufactured at Siemens’ facility in Vadodara, the kit is capable of delivering results in just 40 minutes—dramatically faster than traditional methods, which usually take between one to two hours. With a production capacity of one million reactions per year, the IMDX Monkeypox Detection RT-PCR Assay is poised to play a crucial role in India’s public health strategy.
The kit has been clinically validated by the ICMR-National Institute of Virology in Pune, achieving 100% sensitivity and specificity, in line with both Indian and global standards. Designed to be platform-agnostic, the test integrates seamlessly into existing lab workflows, leveraging the infrastructure established for COVID-19 testing to maximize efficiency.
As monkeypox continues to pose a global threat, this indigenous RT-PCR kit represents a critical advancement in India’s capability to respond swiftly and effectively to the public health emergency.