Boditech Med Receives ANVISA Approval for Four Diagnostic Kits for Dengue Fever and Latent TB

- 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.”