CDSCO Approves Indigenous Mpox RT-PCR Test with 40-Minute Results
Tuesday, 27 August 2024, 14:20 IST
In response to the ongoing Mpox outbreak, Siemens Healthineers announced that the Central Drugs Standard Control Organization (CDSCO) has approved an indigenous RT-PCR test for the infectious disease, capable of delivering results in just 40 minutes. The company stated that it has received manufacturing approval from CDSCO for the IMDX Monkeypox Detection RT-PCR Assay.
“This is a significant achievement for our 'Make in India' initiative and a critical advancement in the fight against the Monkeypox public health emergency”, said the company.
This development follows the World Health Organization's declaration earlier this month of Mpox as a global health emergency. The deadly infectious disease is currently causing an outbreak in Africa, primarily driven by the more virulent and lethal Clade Ib. Outside Africa, Clade Ib has spread to Sweden and Thailand, with one case reported in each country so far.
"The novel test can produce results in just 40 minutes, significantly faster than traditional methods (which take 1-2 hours)”, the company said. This helps reduce the turnaround time for reporting, leading to quicker responses.
The test has also been clinically validated by ICMR-National Institute of Virology, Pune. It boasts an impressive 100 percent sensitivity and specificity. “IMDX Monkeypox RTPCR Assay kits adhere to Indian statutory guidelines and comply with the highest global standards”, the company said.
“The urgency for precise and accurate diagnostics couldn't be more crucial than now”, said Hariharan Subramanian, Managing Director, Siemens Healthcare. “By providing India with advanced assay kits tailored to combat Monkeypox, we are taking a proactive stance in battling this disease and prioritizing prompt and precise detection that can truly make a difference in saving lives”, he added.
The company also announced that the RT-PCR test will be produced at its molecular diagnostics manufacturing facility in Vadodara, Gujarat. The factory, which has an annual capacity of 1 million reactions, is fully prepared to make the kits available, according to the company. The groundbreaking molecular diagnostic test RT-PCR test targets two distinct regions in the viral genome. It spans both clade I and clade II variants of the virus. This ensures thorough detection across various viral strains, providing comprehensive results.
Clade II was behind the 2022 Mpox outbreak that spread to over a hundred countries. The company highlighted that the RT-PCR test is platform-agnostic, allowing it to integrate seamlessly into existing lab workflows with standard PCR setups. This means no new instruments are needed, and the test can be utilized on existing Covid testing infrastructure, boosting its efficiency.
“This is a significant achievement for our 'Make in India' initiative and a critical advancement in the fight against the Monkeypox public health emergency”, said the company.
This development follows the World Health Organization's declaration earlier this month of Mpox as a global health emergency. The deadly infectious disease is currently causing an outbreak in Africa, primarily driven by the more virulent and lethal Clade Ib. Outside Africa, Clade Ib has spread to Sweden and Thailand, with one case reported in each country so far.
"The novel test can produce results in just 40 minutes, significantly faster than traditional methods (which take 1-2 hours)”, the company said. This helps reduce the turnaround time for reporting, leading to quicker responses.
The test has also been clinically validated by ICMR-National Institute of Virology, Pune. It boasts an impressive 100 percent sensitivity and specificity. “IMDX Monkeypox RTPCR Assay kits adhere to Indian statutory guidelines and comply with the highest global standards”, the company said.
“The urgency for precise and accurate diagnostics couldn't be more crucial than now”, said Hariharan Subramanian, Managing Director, Siemens Healthcare. “By providing India with advanced assay kits tailored to combat Monkeypox, we are taking a proactive stance in battling this disease and prioritizing prompt and precise detection that can truly make a difference in saving lives”, he added.
The company also announced that the RT-PCR test will be produced at its molecular diagnostics manufacturing facility in Vadodara, Gujarat. The factory, which has an annual capacity of 1 million reactions, is fully prepared to make the kits available, according to the company. The groundbreaking molecular diagnostic test RT-PCR test targets two distinct regions in the viral genome. It spans both clade I and clade II variants of the virus. This ensures thorough detection across various viral strains, providing comprehensive results.
Clade II was behind the 2022 Mpox outbreak that spread to over a hundred countries. The company highlighted that the RT-PCR test is platform-agnostic, allowing it to integrate seamlessly into existing lab workflows with standard PCR setups. This means no new instruments are needed, and the test can be utilized on existing Covid testing infrastructure, boosting its efficiency.
