Siemens Healthineers announced on Tuesday that it has received approval from the Central Drugs Standard Control Organisation (CDSCO) to manufacture a Monkeypox (M-pox) detection RT-PCR kit. The approval of this locally developed kit marks a significant step in addressing the ongoing Monkeypox public health emergency, the company stated.
The IMDX Monkeypox Detection RT-PCR Assay will be produced at Siemens Healthineers’ molecular diagnostics facility in Vadodara, which has the capacity to produce 1 million tests annually. The kit provides results in just 40 minutes, considerably faster than the traditional methods that typically take 1 to 2 hours, thereby enabling quicker diagnostic responses.
Clinically validated by the ICMR-National Institute of Virology in Pune, the kit boasts 100 percent sensitivity and specificity, ensuring reliable and accurate detection, the company added. “The need for precise diagnostics is more urgent than ever. By delivering advanced assay kits specifically designed to detect Monkeypox, we are taking a proactive approach to combating this disease and ensuring rapid and accurate detection to help save lives,” said Hariharan Subramanian, Managing Director of Siemens Healthcare.
On August 14, the World Health Organisation declared the Monkeypox outbreak a public health emergency of international concern, following a surge in cases in parts of Africa. In India, approximately 30 cases of Monkeypox have been reported since 2022, with the latest case identified in March 2024.
