Boditech Med

• Products classified as Class III high-risk medical devices; approved following local clinical performance evaluations
• Approval for dengue antigen and antibody kits enables detection of primary and secondary infections
• Entry into the Latin American infectious disease diagnostics market expected to drive revenue growth

Boditech Med, a leading provider of point-of-care diagnostics, announced on the 23rd that it has received product approval from Brazil’s National Health Surveillance Agency (ANVISA) for four diagnostic kits, including two for dengue fever and two for latent tuberculosis (LTBI).

The newly approved products include:

• ichroma™ Dengue NS1 Ag (antigen detection)

• ichroma™ Dengue IgG/IgM (antibody detection)

• ichroma™ IGRA-TB and AFIAS IGRA-TB for latent tuberculosis detection

These products have been classified as Class III high-risk medical devices under Brazilian regulations. In particular, the dengue diagnostic kits underwent local clinical performance evaluation as part of the approval process.

Dengue fever has emerged as a major global infectious disease, spreading across Asia, Latin America, and Africa due to climate change and urbanization, which have expanded mosquito habitats. According to the World Health Organization (WHO), more than 14 million cases were officially reported worldwide in 2024—over double the record-setting 2023 total. Brazil alone accounted for over 10 million cases, representing more than 70% of the global total. Unofficial estimates suggest that the actual global number of infections ranges between 100 million and 400 million annually.

While primary dengue infections may present mild symptoms such as fever, headache, and rash, secondary infections can trigger severe complications due to an excessive immune response. For this reason, a dual diagnostic approach using both antigen (NS1) and antibody (IgG/IgM) tests is clinically important. With this ANVISA approval, Boditech Med is now equipped with a complete diagnostic platform capable of differentiating between primary and secondary dengue infections.

Latent tuberculosis infection (LTBI) refers to a state where individuals are infected with Mycobacterium tuberculosis but do not exhibit symptoms or transmit the disease. However, 5–10% of LTBI carriers eventually develop active tuberculosis. According to WHO, over 10 million people contract tuberculosis each year, and approximately 25% of the global population is estimated to be latently infected. Brazil is one of the WHO-designated high-burden TB countries, with over 70,000 new cases reported annually.

Boditech Med’s IGRA-based diagnostic kits, which utilize the Interferon-Gamma Release Assay method, offer a fast and convenient solution for identifying LTBI. These tools are expected to play a critical role in enhancing early detection and preventing the progression to active tuberculosis, particularly in high-risk countries like Brazil.

Eui-yeol Choi, CEO of Boditech Med, stated:

“Brazil is a key player in the Latin American POCT market, and this approval represents a significant step in supporting the country’s efforts to combat both tuberculosis and dengue fever. Meeting ANVISA’s rigorous regulatory standards also reinforces confidence in our products and positions us for meaningful revenue growth in Brazil and the wider Latin American market.”

• New factory established in Jhajjar, India to enhance price competitiveness through local production
• Targets $75 million (approx. 100 billion KRW) in sales from the Indian market; aims to serve as a strategic hub for South Asia and the Middle East
• Pilot production underway, with full-scale manufacturing to begin in Q3 for faster and more cost-effective supply

Boditech Med, a global leader in point-of-care diagnostics, announced on the 7th that it held a successful completion ceremony for its new manufacturing facility located in Jhajjar, India. The new plant is a key part of the company’s strategy to strengthen its presence in the Indian, South Asian, and Middle Eastern markets through local production and enhanced cost competitiveness.

The event was attended by Boditech Med CEO Eui-yeol Choi, Sung-ho Lee, Ambassador of the Republic of Korea to India, local government officials, key partners, and regional leaders.

The Jhajjar facility spans 10,032 square meters (approx. 3,035 pyeong) and will initially focus on the production of high-demand diagnostic kits, including TSH, T3, T4 (thyroid function) and HbA1c (glycated hemoglobin). Production is planned to gradually expand to include a wider range of ichroma™ diagnostic kits.

Currently, pilot production is underway for four diagnostic products, and local manufacturing approvals are expected to be completed by the first half of this year. Full-scale mass production and sales are scheduled to begin in Q3 2025, which is expected to reduce production costs and logistics expenses while enabling faster product supply across the region.

Since entering the Indian market in 2015, Boditech Med has recorded an average annual growth rate of 34%, with 2024 sales reaching $9 million (approx. 12 billion KRW). With the new facility as a foundation, the company plans to further accelerate growth and aims to achieve $75 million (approx. 100 billion KRW) in annual sales and over 5% market share in India by 2030.

Eui-yeol Choi, CEO of Boditech Med, stated,

“India, now the world’s most populous country, is experiencing a rapid surge in demand for point-of-care diagnostics. The primary objective of the new plant is to increase our market share in India, while gradually scaling production to establish it as a strategic base for broader expansion into South Asia and the Middle East.”

He added,

“In the mid- to long-term, our headquarters in Chuncheon will focus on the production of automated AFIAS diagnostic solutions, while ichroma™ products will be manufactured across both domestic and overseas production bases.”

• CE-IVDR certification process successfully completed for products sold across Europe.
• Products verified to meet increasingly stringent global certification standards.
• Additional certifications for molecular diagnostics and drug testing products underway.

Boditech Med, a leader in point-of-care diagnostics, announced on November 3rd that it has successfully completed CE-IVDR (In Vitro Diagnostic Regulation) certification for 14 diagnostic devices and 142 diagnostic kits.

The CE-IVDR is a regulation that has been mandatory for all member states of the European Union (EU) since May 2022. Diagnostic devices and kits sold in Europe are required to comply with this certification.

Boditech Med initiated the CE-IVDR certification process in November 2023 with 22 diagnostic kits and completed approvals for all its products sold in Europe through two additional phases this year. The 14 certified diagnostic devices include seven models under the ichroma brand and four under the AFIAS brand. The certified diagnostic kits cover a broad range of categories: 47 hormone-related products, 25 infectious disease products, 20 cancer-related products, 9 cardiovascular products, and 20 therapeutic drug monitoring products.

The CE-IVDR applies not only to the 27 EU member states but also to four European Free Trade Association (EFTA) countries—Iceland, Liechtenstein, Norway, and Switzerland—as well as Northern Ireland and Turkey. Moreover, global certification standards for diagnostic products have become increasingly stringent following the COVID-19 pandemic. Many countries, including Australia, Canada, Japan, Singapore, and Vietnam, have either introduced or are preparing to implement certification systems similar to the CE-IVDR.

Eui-yeol Choi, CEO of Boditech Med, commented, “The proportion of revenue from Europe has increased from less than 10% in 2019 to over 20% for three consecutive years, marking the highest share among our regional markets. During the same period, our sales in Europe have grown more than fourfold. We are currently active in 34 European countries, with rapid sales growth in Southern Europe, particularly Italy, alongside strong performance in Western Europe, including Switzerland, Germany, and France.”

He added, “In line with this growth, we have completed the certification process for all products sold in Europe, including therapeutic drug monitoring products expected to drive future revenue. Additionally, we are preparing to secure approvals for molecular diagnostics and DOA (Drugs of Abuse) products.”