India’s First Mpox Testing Kit Launched by AMTZ, Transasia Bio-Medicals

The World Health Organization (WHO) has declared a second public health emergency in response to the rapid global spread of a more virulent and lethal strain of the Mpox virus. The threat of monkeypox has been spreading to new regions beyond Africa. While the Union Government has assured that there are no severe cases in India so far, the preparedness for a potential outbreak is underway. One such step towards preparedness was recently taken by Andhra Pradesh MedTech Zone (AMTZ) and Transasia Diagnostics, who have developed the first indigenous RT-PCR kit in India for testing and diagnosing Mpox. The kit was commercially launched under the brand name ErbaMDx Monkeypox RT-PCR Kit. This marks a significant milestone as the country’s first indigenously developed testing solution for Mpox.

The kit has undergone rigorous validation by the Indian Council for Medical Research (ICMR) and has received emergency authorization from the Central Drugs Standard Control Organisation (CDSCO), which is part of the Ministry of Health and Family Welfare. Pricing details will be announced later.

Notably, the first Mpox testing kit in India features lyophilized components, allowing it to be shipped and stored at room temperature. This is especially crucial for areas with limited cold chain infrastructure, as it helps make such essential diagnostic tools accessible even to remote locations. Additionally, the kit has a 12-month shelf life and zero cross-reactivity with other orthopoxviruses, confirming the reliability of the kit.

The production capabilities of Transasia Diagnostics (P) Ltd at the state-of-the-art IVD facility in AMTZ supports manufacturing of over 50 million Monkeypox tests per month. The manufacturing of ErbaMDx Monkeypox RT-PCR Kit is supported at AMTZ under the leadership of Dr J K Sharma, MD & CEO, AMTZ, with Dr K Susheela Branham, Head of Biologics and Diagnostics, AMTZ.

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