Siemens Healthineers Gets Green Light to Produce Mpox Detection Kits In India

Siemens Healthineers announced on Tuesday that it has secured approval from the Central Drugs Standard Control Organisation (CDSCO) to manufacture a monkeypox (mpox) detection RT-PCR kit in India, marking a significant step in the country’s efforts to enhance its diagnostic capabilities for the virus.

The approval of the locally developed mpox detection kit is a major breakthrough in the battle against the virus, according to Siemens Healthineers. This milestone will play a crucial role in addressing the public health emergency posed by monkeypox, enabling faster and more accurate diagnosis to combat its spread, the company said

Siemens Healthineers will produce the IMDX Monkeypox Detection RT-PCR Assay at its Vadodara facility, which has the capacity to manufacture up to 1 million test reactions annually, enabling a significant scale-up in diagnostic testing for Monkeypox.

The new monkeypox detection kit provides results in just 40 minutes, much faster than traditional methods, allowing for quicker action and response to the virus.

The mpox detection kit, validated by ICMR-National Institute of Virology, Pune, offers 100% accuracy and sensitivity. According to Hariharan Subramanian, MD of Siemens Healthcare, “With the urgency for precise diagnostics at an all-time high, our advanced assay kits will play a crucial role in combating Monkeypox in India, prioritizing prompt and accurate detection to save lives.”

Following a surge in cases in Africa, the World Health Organization (WHO) declared the monkeypox outbreak a global health emergency on August 14. In India, where around 30 cases have been reported since 2022, the most recent case was detected in March 2024, highlighting the ongoing need for vigilance and diagnostic capabilities to combat the virus.

(Nazwin Basheer has produced this article as part of a Timeline Internship Programme)