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New Delhi, August 27, 2024 – In a significant stride towards bolstering public health, India has launched an indigenous RT-PCR testing kit designed for the rapid detection of Monkeypox. The launch comes in response to the World Health Organization’s (WHO) declaration of Monkeypox as a public health emergency of international concern due to the virus’s increasing transmissibility and mortality rates.
The newly developed kit, named IMDX Monkeypox Detection RT-PCR Assay, has received approval from the Central Drugs Standard Control Organisation (CDSCO), marking a pivotal moment in India’s ongoing ‘Make in India’ initiative. The initiative aims to promote the production of critical healthcare tools within the country, reducing dependence on international imports and enhancing the nation’s self-reliance in healthcare.
The IMDX Monkeypox Detection RT-PCR Assay is set to be manufactured at Siemens Healthineers’ molecular diagnostics unit in Vadodara, Gujarat, which has the capacity to produce one million reactions annually. The kit has been meticulously designed to target two specific regions in the Monkeypox viral genome, ensuring comprehensive detection across multiple strains. This feature allows for accurate identification of the virus, even as it mutates, and integrates seamlessly into existing laboratory workflows, facilitating its adoption across various healthcare settings.
Hariharan Subramanian, Managing Director of Siemens Healthcare Private Limited, highlighted the critical need for precise diagnostics in controlling the spread of Monkeypox. “By providing advanced assay kits tailored to combat Monkeypox, we are prioritizing prompt and accurate detection, which is crucial for saving lives,” Subramanian stated.
Clinically validated by the Indian Council of Medical Research-National Institute of Virology (ICMR-NIV) Pune, the RT-PCR assay kit delivers results in just 40 minutes. This rapid turnaround time represents a significant improvement over traditional testing methods, which can take hours or even days to produce results. Furthermore, the kit boasts 100% sensitivity and specificity, ensuring that it can detect the virus with unparalleled accuracy, thereby minimizing the risk of false positives or negatives.
The development and approval of this indigenous RT-PCR kit underline India’s commitment to strengthening its healthcare infrastructure in response to global health challenges. As the Monkeypox virus continues to pose a serious threat worldwide, India’s proactive approach in developing and deploying this diagnostic tool is expected to play a crucial role in controlling the spread of the virus and protecting public health.
This achievement is not only a testament to India’s scientific and technological capabilities but also reinforces the importance of self-reliance in the face of global health emergencies. With the IMDX Monkeypox Detection RT-PCR Assay now available, India is better equipped to respond swiftly and effectively to the evolving Monkeypox threat, safeguarding the health of its citizens and contributing to global efforts to combat the virus.
