India develops rapid RT-PCR test for monkeypox amid WHO global health emergency

India has made a significant stride in its fight against the global monkeypox outbreak with the development of a home-grown RT-PCR testing kit.

Siemens Healthineers’ IMDX Monkeypox Detection RT-PCR Assay has received approval from the Central Drugs Standard Control Organisation (CDSCO), marking a crucial milestone in the "Make in India" initiative and a vital tool in combating the monkeypox public health emergency.

This approval comes as the World Health Organization (WHO) declares its second public health emergency of international concern due to the new, more transmissible and deadly strain of the monkeypox virus, Clad-1.

The indigenous test kit by Siemens is designed to provide rapid and accurate detection of the virus, covering both clade I and clade II variants.

According to Siemens Healthcare Private Limited, the kit can deliver results in just 40 minutes, a significant improvement over traditional methods that typically take one to two hours.

Hariharan Subramanian, Managing Director of Siemens Healthcare Private Limited, emphasised the importance of timely and accurate diagnostics in the ongoing fight against monkeypox.

“By providing India with advanced assay kits tailored to combat monkeypox, we are taking a proactive stance in battling this disease. Prompt and precise detection can truly make a difference in saving lives,” Subramanian stated.

The IMDX Monkeypox Detection RT-PCR Assay will be manufactured at Siemens' facility in Vadodara, which can produce one million reactions per year. This platform-agnostic test is designed to integrate seamlessly into existing lab workflows, utilising the COVID-19 testing infrastructure to enhance efficiency.

Clinically validated by ICMR-National Institute of Virology in Pune, the assay boasts 100% sensitivity and specificity, adhering to both Indian statutory guidelines and global standards.