In a significant leap forward for India’s “Make in India” initiative, the country has developed its first indigenous RT-PCR kit for the detection of Monkeypox (Mpox). The kit, known as the IMDX Monkeypox Detection RT-PCR Assay, has received manufacturing approval from the Central Drugs Standard Control Organisation (CDSCO), marking a critical milestone in India’s fight against the global Monkeypox health emergency.

The development comes in the wake of the World Health Organization (WHO) declaring Monkeypox as its second public health emergency of international concern. The new strain of the virus, Clad-1, is noted for its higher transmissibility and increased mortality rates, underscoring the urgent need for precise and reliable diagnostic tools.

Manufactured by Siemens Healthcare Private Limited, the IMDX Monkeypox Detection RT-PCR Assay is designed to target two distinct regions of the viral genome, covering both Clade I and Clade II variants. This comprehensive approach ensures that the assay can detect a wide range of viral strains, providing accurate and thorough results.

“This indigenous RT-PCR kit is a groundbreaking advancement in molecular diagnostics, particularly in the context of the Monkeypox outbreak,” said Hariharan Subramanian, Managing Director of Siemens Healthcare Private Limited. “In a time where accurate and timely diagnostics are paramount, this assay represents a proactive effort to enhance our healthcare infrastructure and provide rapid, precise detection capabilities.”
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One of the standout features of the IMDX assay is its adaptability. It is platform-agnostic, meaning it can be integrated seamlessly into existing laboratory workflows using standard PCR setups. This flexibility allows for the use of existing COVID-19 testing infrastructure, significantly enhancing the efficiency of Monkeypox detection across the country.

The assay’s performance has been clinically validated by the ICMR-National Institute of Virology in Pune, boasting an impressive 100% sensitivity and specificity. Additionally, the test delivers results in just 40 minutes, a significant reduction from the traditional 1-2 hour timeframe, enabling quicker responses in critical situations.

“Our molecular diagnostics manufacturing unit in Vadodara is fully equipped with the capacity to produce 1 million assay reactions per year,” added Subramanian. “This capability will ensure the widespread availability of these kits, which are crucial in our efforts to combat the Monkeypox outbreak.”

The IMDX Monkeypox Detection RT-PCR Assay is a testament to India’s growing prowess in biotechnology and molecular diagnostics, aligning with the nation’s broader goals of improving access to advanced healthcare solutions and strengthening its public health response capabilities.

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