India's indigenous RT-PCR testing kit for Mpox approved by CDSCO, delivers results in 40 mins: Report

Siemens Healthineers’ IMDX Monkeypox Detection RT-PCR Assay has received manufacturing approval from the Central Drugs Standard Control Organisation (CDSCO).

India has successfully developed and received approval for its home-grown RT-PCR testing kit for Mpox, a development sanctioned by the Central Drugs Standard Control Organisation (CDSCO). This new testing kit is a significant advancement in the country's efforts to combat Mpox and enhance its public health response, reported ANI.

The World Health Organization (WHO) has declared a second public health emergency of international concern due to a new strain of monkeypox, identified as Clad-1. This strain is reported to be more transmissible and has higher mortality rates than previous versions, prompting urgent global health measures.

Siemens Healthineers’ IMDX Monkeypox Detection RT-PCR Assay has received manufacturing approval from the Central Drugs Standard Control Organisation (CDSCO). This milestone represents a major success for India’s "Make in India" initiative and is a crucial step forward in addressing the ongoing Monkeypox public health emergency.

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"IMDX Monkeypox Detection RT-PCR Assay will be manufactured at our molecular diagnostics manufacturing unit in Vadodara, which has a manufacturing capacity of 1 million reactions per year. The factory is all set to make the kits available," said Siemens Healthcare Private Ltd.

The IMDX Monkeypox Detection RT-PCR Assay, developed by Siemens Healthineers, has been granted manufacturing approval by the Central Drugs Standard Control Organisation (CDSCO). This cutting-edge test targets two distinct regions in the viral genome, covering both clade I and clade II variants of Monkeypox, ensuring comprehensive detection. Its platform-agnostic design allows it to integrate seamlessly into existing lab workflows with standard PCR setups, making efficient use of current COVID testing infrastructure, the report added.

Siemens Healthineers' IMDX Monkeypox Detection RT-PCR Assay offers results in just 40 minutes—much faster than traditional methods that take 1-2 hours. Clinically validated by the ICMR-National Institute of Virology, Pune, the assay boasts 100 percent sensitivity and specificity. It adheres to Indian statutory guidelines and meets the highest global standards, enhancing diagnostic efficiency and speed in responding to the Monkeypox public health emergency, reported ANI.