In a ground-breaking achievement for India’s medical diagnostics sector, Erba Transasia proudly announces the commercial launch of the country’s first indigenously manufactured MonkeyPox PCR test kit. Validated by the Indian Council for Medical Research (ICMR), this kit today received emergency approval from Central Drugs Standard Control Organisation (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. The newly launched ErbaMDx MonkeyPox RT-PCR Kit represents a significant advancement, providing a highly accurate confirmatory test for MonkeyPox, as compared to rapid tests.

The recent declaration by the World Health Organization (WHO) of the MPox outbreak as a Public Health Emergency of International Concern underscores the urgency for effective diagnostic solutions. The recent global surge in Mpox cases has prompted several countries, particularly in Europe, to raise their alert levels. The European Centre for Disease Prevention and Control (ECDC) has upgraded its risk assessment to “moderate” due to a new strain detected in Sweden. In response to the global situation, the Indian Health Ministry has also emphasized the need for effective surveillance and has geared up a network of 32 testing laboratories across the country for early diagnosis.

In response to this health emergency, Erba Transasia has introduced the MonkeyPox RT-PCR Kit, an innovative assay characterized by its high sensitivity and ease of use. The kit features a uniquely formulated primer and probe, ensuring enhanced accuracy in detection. This advanced technology has been validated through rigorous testing, which confirms its robustness and reliability.

The ErbaMDx kit is notable for its cost-effectiveness and user-friendly design, enabling its widespread use both in India and globally. The kit’s lyophilized components, which allow for shipping and storage at ambient temperatures, are particularly advantageous for deployment in regions with limited cold chain infrastructure. This feature expands access to reliable diagnostics in underserved areas, helping to bridge the healthcare gap in critical situations.

Mr. Suresh Vazirani, Founder Chairman, Erba Transasia Group, said, “As a leading manufacturer of clinical diagnostic solutions, we are committed to utilizing our well-established manufacturing and rapid response capabilities to strengthen epidemic preparedness and increase access to life-saving diagnostics for those who need them most at an affordable price. Our manufacturing facility in AMTZ, which is Asia’s largest, enables us to respond more rapidly and equitably to public health disease outbreaks, particularly in countries where access to diagnostic services are limited.”

The ErbaMDx MonkeyPox RT-PCR kit delivers 97.5% sensitivity and 100% specificity, with results available in less than an hour. It leverages existing COVID-19 lab infrastructure and has a 12-month shelf life.

Further, the kit is designed to ensure zero cross-reactivity with other orthopox viruses or organisms, thereby enhancing its diagnostic precision. Further the kit is designed for use with commercially available open-platform real-time PCR systems equipped with a minimum of three optical channels. Consequently, it is suitable for application in any PCR testing laboratory developed for molecular diagnostics testing during the COVID-19 pandemic.

The production capabilities of Transasia Diagnostic Pvt Ltd. (TDPL) at the state-of-the-art IVD facility in Andhra Pradesh MedTech Zone (AMTZ) support the manufacturing of over 50 million MPox tests per month, ensuring a robust supply to meet the growing global demand. The first batch of MPox kit from Erba Transasia will be made available very soon.

This launch marks a significant milestone in India’s healthcare sector, demonstrating the country’s capacity to lead in global health solutions through local innovation and expertise.

Incepted in the year 1979, Transasia Bio-Medicals Ltd., is headquartered in Mumbai, India. It is recognized as India’s Leading In-vitro Diagnostic Company and offers solutions and products in Biochemistry, Hematology, Coagulation, ESR, Immunology, Urinalysis, Critical Care, Diabetes Management and Molecular Diagnostics.

Transasia Bio-Medicals manufactures and markets equipment and reagents, with an impressive install base of above 90,000 equipment across 50,000 laboratories in India. The vast network of more than 400 service engineers, 500+ sales and marketing team, 26 zonal offices, and 550+ channel partners allows us to reach out to over 5000 tier II-IV cities, towns and villages including the farthest north-eastern regions in a record time of just 4-5 hours. In fact, Transasia boasts of the largest team of sales and service personnel in the Indian IVD Industry!

Transasia has long endorsed the ‘Make in India’ concept, much before it actually came into existence! In fact it is the first Indian company to manufacture and export state-of-the-art blood analyzers and reagents, way back in the 1990s. The latest technologies from its European subsidiaries at Czech Republic and France, are adopted and customized in India at the five manufacturing facilities at Baddi, Daman, Sikkim, Mumbai and Visakhapatnam, to develop products and solutions that aid in timely diagnosis.

Erba Transasia leaves no stone unturned in order to provide quality, accurate and affordable diagnostic solutions. Over 150 crore blood tests are done on an Erba Transasia equipment every year benefitting more than 200 million people.