India's Indigenous mpox detection RT-PCR kit gets manufacturing nod from CDSCO

The IMDX Monkeypox Detection RT-PCR Assay, a molecular diagnostic test targets 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 the efficiency.

According to the Company, the assay helps reduce the turnaround time for reporting with results available in just 40 minutes, significantly faster than traditional methods (which take 1-2 hours). Clinically validated by ICMR-National Institute of Virology, Pune, the assay boasts an impressive 100% sensitivity and specificity. IMDX Monkeypox RTPCR Assay kits adhere to Indian statutory guidelines and comply with the highest global standards.

Hariharan Subramanian, Managing Director, Siemens Healthcare Private Limited said, “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 prioritizing prompt and precise detection that can truly make a difference in saving lives. These kits are a testament to our focus on improving 'Access to Care' and these assay kits are a significant step toward that goal."