Listen to Story India's drug regulator has given its approval to Siemens Healthineers to manufacture testing kits for mpox. After the World Health Organisation (WHO) declared mpox, formerly called monkeypox, as a disease of global health concern , India has ramped up facilities in detecting, monitoring and treating mpox. The Central Drugs Standard Control Organisation (CDSCO) has given its manufacturing approval to the company to create RT-PCR kits to detect mpox in people.
"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, as per news agency ANI. The company added that the test will target 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," they said.
The Indian Council of Medical Research-National Institute of Virology, Pune, has clinically validated the testing, which boasts 100% sensitivity and specificity. The RT-PCR kits adhere to Indian statutory guidelines and compl.