The World Health Organization (WHO) has declared Monkeypox as a global public health emergency for the second time due to the emergence of a more transmissible strain (Clade 1), known for its higher mortality rates.
In response, India has successfully developed an indigenous RT-PCR testing kit for Mpox, which has now received approval from the Central Drugs Standard Control Organisation (CDSCO).
The IMDX Monkeypox Detection RT-PCR Assay, produced by Siemens Healthineers, has been granted manufacturing approval by CDSCO. This approval marks a significant milestone for India’s “Make in India” initiative and strengthens the country’s ability to tackle the ongoing Monkeypox public health crisis.
The manufacturing of the IMDX Monkeypox Detection RT-PCR Assay will take place at Siemens Healthineers’ molecular diagnostics facility in Vadodara, which has a production capacity of one million reactions annually. The company has assured that the kits will be readily available soon.
The assay is designed to detect two specific regions in the viral genome, covering both Clade I and Clade II variants, ensuring comprehensive detection across different strains. Importantly, this test is platform-agnostic and can be integrated seamlessly into existing PCR lab setups, utilizing existing COVID-19 testing infrastructure, thereby enhancing operational efficiency.
Hariharan Subramanian, Managing Director at Siemens Healthcare Private Limited, emphasized the critical need for rapid and accurate diagnostics. “In providing advanced assay kits tailored for Monkeypox, we are prioritizing timely and precise detection, which can have a profound impact on saving lives. This development aligns with our commitment to improving access to care and marks a significant step toward achieving that goal,” he said.
The IMDX Monkeypox Detection RT-PCR Assay delivers results within 40 minutes, significantly faster than conventional methods, which typically take 1-2 hours. Clinically validated by the ICMR-National Institute of Virology in Pune, the assay has demonstrated 100% sensitivity and specificity. The kits also meet Indian statutory guidelines and adhere to global standards.
