India develops indigenous mpox detection RT-PCR kit, gets CDSCO nod

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.

Now, India has developed its own home-grown indigenous RT-PCR testing kit to fight against Mpox, which 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.

"The IMDX Monkeypox Detection RT-PCR Assay is a ground-breaking molecular diagnostic test that targets two distinct regions in the viral genome, spanning both clade I and clade II variants of the virus. This ensures thorough detection across various viral strains, providing comprehensive results. Notably, this assay is platform-agnostic and seamlessly fits into existing lab workflows with standard PCR setups, eliminating the need for new instruments. The ability to use existing COVID testing infrastructure would enhance efficiency." It went further.

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.

According to Siemens Healthcare Private Ltd, 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," it said.