monkeypox: India develops indigenous Monkeypox RT-PCR testing kit, gets CDSCO approval

monkeypox: India develops indigenous Monkeypox RT-PCR testing kit, gets CDSCO approval

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India has developed its own home-grown indigenous RT-PCR testing kit to fight against Monkeypox, reported ANI on Tuesday. The assay has been approved by Central Protection Drugs Standard Control Organisation (CDSCO).

IMDX Monkeypox Detection RT-PCR Assay by Siemens Healthineers has received manufacturing approval from the Central Drugs Standard Control Organisation (CDSCO). This is a significant achievement for our “Make in India” initiative and a critical advancement in the fight against the Monkeypox public health emergency.

“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.

According to the company, the test results will be available in 40 minutes.

“With results available in just 40 minutes, significantly faster than traditional methods (which take 1-2 hours), the assay helps reduce the turnaround time for reporting, leading to quicker responses. Clinically validated by ICMR-National Institute of Virology, Pune, the assay boasts an impressive 100 per cent sensitivity and specificity. IMDX Monkeypox RTPCR Assay kits adhere to Indian statutory guidelines and comply with the highest global standards,” ANI quoted the company as saying.

Hariharan Subramanian, Managing Director, Siemens Healthcare Private Limited, said that the urgency for precise and accurate diagnostics couldn’t be more crucial than now.”By providing India with advanced assay kits tailored to combat Monkeypox, we are taking a proactive stance in battling this disease and prioritising prompt and precise detection that can truly make a difference in saving lives. These kits are a testament to our focus on improving ‘Access to Care’ and these assay kits are a significant step towards that goal,” he said.The World Health Organisation (WHO) has announced its second public health emergency of International concern due to Monkey Pox. The new strain of this virus (Clad-1) is considered to be more transmissible and has higher mortality rates.

(With inputs from ANI)

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