Breaking News: CDSCO Approves Groundbreaking Indigenous Mpox RT-PCR Test with Rapid 40-Minute Results | MorungExpress
New Delhi, August 27 (IANS):
Amid the ongoing Mpox outbreak, the Central Drugs Standard Control Organization (CDSCO) has approved an indigenous RT-PCR test capable of delivering results in just 40 minutes. Siemens Healthineers announced on Tuesday that they received manufacturing approval from CDSCO for the IMDX Monkeypox Detection RT-PCR Assay.
“This notable achievement aligns with our ‘Make in India’ initiative and marks a critical advancement against the Monkeypox public health emergency,” Siemens Healthineers stated.
The announcement follows the World Health Organization’s recent declaration of Mpox as a global health emergency. The disease is currently causing significant outbreaks in Africa, driven by the more virulent Clade Ib, and has spread to Sweden and Thailand, where each country has reported one case.
The new test reduces the turnaround time for reporting to 40 minutes, compared to the traditional 1-2 hours. Clinically validated by the ICMR-National Institute of Virology, Pune, the test boasts 100 percent sensitivity and specificity. The kits conform to Indian statutory guidelines and global standards, said Siemens Healthineers.
“The urgency for precise and accurate diagnostics is crucial now,” emphasized Hariharan Subramanian, Managing Director of Siemens Healthcare. “By providing India with advanced assay kits, tailored to combat Monkeypox, we are prioritizing prompt and accurate detection that can save lives.”
The RT-PCR test will be produced at Siemens Healthineers’ molecular diagnostics manufacturing unit in Vadodara, Gujarat, with an annual capacity of 1 million reactions. The new test targets two distinct regions in the viral genome, encompassing both Clade I and Clade II variants, ensuring comprehensive detection across viral strains. Notably, the test is platform-agnostic, fitting seamlessly into existing lab workflows and utilizing existing Covid testing infrastructure, enhancing its efficiency and utility.
This groundbreaking diagnostic test represents a significant step forward in India’s ability to respond quickly and effectively to the Mpox outbreak.
Original Story https://www.morungexpress.com/cdsco-approves-indigenous-mpox-rt-pcr-test-that-delivers-results-in-40-mins
Category : Health , India
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