Mpox: Drug regulator accepts the domestic RT-PCR kit made in India
Siemens Healthineers’ IMDX Monkeypox Detection RT-PCR Assay has been approved for manufacture by the Central Drugs Standard Control Organization (CDSCO).
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Due to monkey pox, the World Health Organization (WHO) has declared its second public health emergency of international concern. This virus’s novel strain, known as Clad-1, is thought to be more contagious and to have a greater death rate.
In order to combat mpox, India has now created a domestic RT-PCR diagnostic kit that has been authorized by the Central Protection Drugs Standard Control Organization (CDSCO).
Siemens Healthineers’ IMDX Monkeypox Detection RT-PCR Assay has been approved for manufacture by the Central Drugs Standard Control Organization (CDSCO). This is a major victory for our “Made in India” campaign and a crucial step forward in the fight against the public health disaster caused by monkeypox.
Production Capabilities and Readiness of the IMDX Monkeypox Detection RT-PCR Assay
The IMDX Monkeypox Detection RT-PCR Assay will be produced at our Vadodara molecular diagnostics manufacturing facility, which can produce one million reactions annually. According to Siemens Healthcare Private Ltd., the factory is prepared to start producing the kits.
“The innovative molecular diagnostic test known as the IMDX Monkeypox Detection RT-PCR Assay targets two unique areas of the viral genome, encompassing both the clade I and clade II versions of the virus. This guarantees complete results by thoroughly detecting different virus strains.
Notably, this assay does not require additional instruments because it is platform-agnostic and easily integrates into regular PCR settings in existing lab workflows. Efficiency would be increased by being able to use the current COVID testing infrastructure.” It proceeded farther.
According to Hariharan Subramanian, Managing Director of Siemens Healthcare Private Limited, there has never been a greater pressing need for precise and reliable diagnostics than there is right now.
“We are taking a proactive approach in fighting this disease and prioritizing prompt and precise detection that can truly make a difference in saving lives by supplying India with cutting-edge assay kits designed to combat monkeypox.
” These assay kits are a big step toward our goal of enhancing “Access to Care,” and they are a testament to our focus on that,” he stated.Siemens Healthcare Private Ltd states that the test results will be accessible in forty minutes.
As opposed to existing procedures, which take 1-2 hours to produce data, the assay produces results in just 40 minutes, which speeds up reporting and results in quicker responses.
The assay, which has been clinically verified by the ICMR-National Institute of Virology in Pune, has an astounding 100% sensitivity and specificity.The IMDX Monkeypox RTPCR Assay kits meet the highest international standards and are compliant with Indian legislation norms,” the statement stated.
