India develops indigenous Mpox detection RT-PCR kit

Siemens Healthineers develops IMDX Monkeypox Detection RT-PCR Assay for Mpox, a deadly strain declared a global health emergency.

India has developed its own home-grown RT-PCR testing kit for Mpox (formerly known as monkeypox). The IMDX Monkeypox Detection RT-PCR Assay, developed by healthcare services company Siemens Healthineers, has received manufacturing approval from the Central Protection Drugs Standard Control Organisation (CDSCO). 

On August 14, the World Health Organisation (WHO) declared mpox, which is currently sweeping through west, central, and east African countries, and has also been found in Pakistan, Thailand and other Asian nations, a public health emergency of international concern. While mpox has been around for decades, this time, a deadlier and far more transmissible strain—known as clade 1b—has driven the recent surge in cases. 

"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," the company said.

Test results will be available in 40 minutes, significantly faster than conventional methods that take 1-2 hours, the company said. The assay has been clinically validated by the ICMR-National Institute of Virology, Pune and has a 100 per cent sensitivity and specificity.

Hariharan Subramanian, managing director, Siemens Healthcare Private Limited, said that the urgency for precise and accurate diagnostics was crucial. “By providing India with advanced assay kits tailored to combat Mpox, 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,” he said.

Just a few days ago, Visakhapatnam-based Andhra Pradesh MedTech Zone (AMTZ) had also announced the launch of its ‘ErbaMDx MonkeyPox RT-PCR Kit’, developed in partnership with the Transasia Diagnostics Private Limited.