Siemens Healthineers Revolutionizes Monkeypox Detection in India

In a groundbreaking development for public health, Siemens Healthineers has announced that its locally developed Monkeypox Detection RT-PCR kit has been granted manufacturing approval by the Central Drugs Standard Control Organisation (CDSCO). This critical advancement comes amid the global Monkeypox (M-pox) public health emergency and aims to significantly enhance the speed and accuracy of diagnostics.

In a bold step towards combating the Monkeypox outbreak, Siemens Healthineers has received approval from the CDSCO to manufacture its innovative IMDX Monkeypox Detection RT-PCR Assay. This breakthrough is a collaborative effort with the Indian Council of Medical Research (ICMR), designed to address the urgent need for precise and rapid diagnostics amidst the ongoing health crisis.

The new RT-PCR kit, to be produced at Siemens Healthineers’ state-of-the-art molecular diagnostics unit in Vadodara, boasts an impressive production capacity of up to one million reactions per year. The facility, equipped with cutting-edge technology, ensures that the kit meets the highest standards of quality and efficiency.

One of the most notable features of this kit is its swift turnaround time. Unlike traditional diagnostic methods, which can take between one to two hours, the IMDX Monkeypox Detection RT-PCR Assay delivers results in just 40 minutes. This rapid processing not only accelerates diagnosis but also enables quicker response and containment efforts, a crucial factor in managing outbreaks.

The kit has been clinically validated by the ICMR-National Institute of Virology, Pune, and has achieved a perfect score with 100 percent sensitivity and specificity. This means that the test is exceptionally reliable in detecting the Monkeypox virus, ensuring that false positives and negatives are minimized.

Hariharan Subramanian, Managing Director of Siemens Healthcare, emphasized the importance of this development, stating, “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.”

The World Health Organization (WHO) declared the Monkeypox outbreak a public health emergency of international concern on August 14, following a surge in cases primarily in parts of Africa. Since the declaration, the situation has prompted heightened global vigilance. In India, approximately 30 cases of M-pox have been detected since 2022, with the most recent case reported in March 2024.

Monkeypox, a rare viral disease caused by the monkeypox virus, is part of the Orthopoxvirus genus, which also includes smallpox and cowpox. Although symptoms are milder than those of smallpox, Monkeypox begins with fever, headache, muscle aches, and exhaustion, often accompanied by swelling of lymph nodes—a distinguishing feature from smallpox.

Transmission occurs through contact with infected animals, humans, or contaminated materials, entering the body through broken skin or mucous membranes. Diagnostics for Monkeypox include a range of techniques, with RT-PCR standing out for its precision and speed.

This new development by Siemens Healthineers not only marks a significant milestone in India’s healthcare advancements but also offers a crucial tool in the global fight against Monkeypox. As the world grapples with the complexities of this virus, innovations like the IMDX Monkeypox Detection RT-PCR Assay represent hope and progress in our ongoing battle against infectious diseases. Source: Deccan Herald