Siemens Healthineers Gets CDSCO Nod for M-pox RT-PCR Kit

New Delhi, Aug 27 (PTI) Siemens Healthineers on Tuesday said it has received Central Drugs Standard Control Organisation's (CDSCO) approval for manufacture of Monkeypox detection RT-PCR kit.
The approval for the locally developed kit is a critical advancement in the fight against the Monkeypox (M-pox) public health emergency, the company said.
IMDX Monkeypox Detection RT-PCR Assay will be manufactured at the company's molecular diagnostics unit in Vadodara, which has a production capacity of 1 million reactions per annum.
With results available in just 40 minutes, significantly faster than traditional methods (which take 1-2 hours), the M-pox detection kit helps reduce the turnaround time for reporting, leading to quicker responses, Siemens Healthineers stated.
Clinically validated by ICMR-National Institute of Virology, Pune, the kit boasts an impressive 100 per cent sensitivity and specificity, it added.
"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," Siemens Healthcare MD Hariharan Subramanian said.
The World Health Organisation on August 14 declared the M-pox outbreak a public health emergency of international concern. The move came after a sudden increase in cases was recorded in parts of Africa.
In India, around 30 M-pox cases have been detected since 2022. The most recent case in the country was reported in March 2024.