The World Health Organization (WHO) has declared its second Public Health Emergency of International Concern due to the spread of a new, more transmissible strain of the Monkeypox virus, known as Clade I, which also exhibits higher mortality rates. In response, India has taken a significant step in combating this health crisis by developing its own indigenous RT-PCR testing kit.
The IMDX Monkeypox Detection RT-PCR Assay, developed by Siemens Healthineers, has received manufacturing approval from the Central Drugs Standard Control Organisation (CDSCO). This milestone marks a crucial achievement for India’s “Make in India” initiative and represents a critical advancement in addressing the Monkeypox public health emergency.
“IMDX Monkeypox Detection RT-PCR Assay will be manufactured at our molecular diagnostics facility in Vadodara, with a production capacity of 1 million reactions per year. The factory is fully prepared to make these kits available promptly,” stated Siemens Healthcare Private Ltd.
The IMDX Monkeypox Detection RT-PCR Assay is a cutting-edge molecular diagnostic tool designed to target two distinct regions in the viral genome, covering both Clade I and Clade II variants of the virus. This broad-spectrum detection capability ensures comprehensive and accurate results across various strains of the virus. Importantly, this assay is platform-agnostic, integrating seamlessly into existing laboratory workflows with standard PCR setups, thereby eliminating the need for new instruments. The ability to leverage existing COVID-19 testing infrastructure further enhances operational efficiency.
Hariharan Subramanian, Managing Director of Siemens Healthcare Private Limited, emphasized the critical need for accurate and timely diagnostics in the current health emergency. “By providing India with advanced assay kits specifically designed to combat Monkeypox, we are taking a proactive approach to battling this disease. Our focus is on ensuring prompt and precise detection, which is crucial for saving lives. These kits are a testament to our commitment to improving ‘Access to Care,’ and they represent a significant step toward that goal,” he said.
According to Siemens Healthcare, the test results from the IMDX Monkeypox RT-PCR Assay will be available in just 40 minutes, significantly faster than traditional methods that typically take 1-2 hours. This rapid turnaround time facilitates quicker responses and better disease management. The assay, which has been clinically validated by the ICMR-National Institute of Virology in Pune, boasts 100% sensitivity and specificity. The IMDX Monkeypox RT-PCR Assay kits adhere to Indian statutory guidelines and meet the highest global standards.
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