Boditech Med

• Selected by WHO ERPD to support global dengue response efforts
• Only FIA-based diagnostic products included, highlighting technological differentiation
• Enables accurate identification of both primary and secondary infections through combined antigen and antibody testing

Boditech Med, a global point-of-care diagnostics company, announced on the 27th that two of its dengue diagnostic kits have been selected by the World Health Organization (WHO) for inclusion in the Expert Review Panel for Diagnostics (ERPD).

Recently, WHO released an updated list of medicines and diagnostics for neglected tropical diseases (NTDs). As part of this effort, WHO activated the ERPD to identify high-performing diagnostic products suitable for urgent deployment in the fight against dengue.

Boditech Med’s selected products include:

▪ ichroma™ Dengue NS1 Ag (antigen detection)

▪ ichroma™ Dengue IgG/IgM (antibody detection)

Both are fluorescence immunoassay (FIA)-based point-of-care tests that meet WHO’s performance and quality standards. By combining antigen and antibody detection, they enable effective differentiation between primary and secondary dengue infections, which is clinically critical for early intervention and treatment decisions.

The ERPD serves as a fast-track assessment mechanism to evaluate high-performing in vitro diagnostic (IVD) products that have not yet undergone WHO Prequalification (PQ). Evaluation is conducted by an independent panel of experts, and selection is used as a key reference for procurement decisions by international agencies and national governments.

Out of submissions from around the world, only seven products were selected, with Boditech Med’s kits being the only FIA-based diagnostics on the list. The recommendation is valid for one year and is expected to facilitate international procurement and field deployment in dengue-endemic regions.

According to WHO, more than 14 million dengue cases were officially reported in 2024—over twice the number recorded in 2023. Latin America, particularly Brazil, accounts for over 70% of global cases, underscoring the urgent need for accurate and rapid diagnostics.

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

“Being selected by WHO’s ERPD validates our advanced technology and product reliability on a global level. As the only FIA-based product included, we are proud to offer high-quality diagnostic solutions that will contribute to global infectious disease control and early response efforts.”

• Q1 2025 consolidated revenue reaches $28.7 million (₩39.1 billion), operating profit $5.9 million (₩8.1 billion)
• Sales in MENA region grow over 40%; Africa and Latin America surge by more than 100%
• Marks the first year of strategic expansion into biochemistry, hematology, and veterinary diagnostic

Boditech Med, a global leader in point-of-care diagnostics, announced on May 8 its preliminary financial results for the first quarter of 2025, reporting consolidated revenue of $28.7 million (₩39.1 billion) and operating profit of $5.9 million (₩8.1 billion). This represents a year-on-year increase of 18% in revenue and 37% in operating profit, with an operating margin of 20.7%, reflecting both strong growth and solid profitability.

Broad-based growth across global markets contributed to the company’s performance. The Middle East and North Africa (MENA) region accounted for 25% of total revenue, growing by more than 40% compared to the same period last year. Markets in Africa and Latin America, which had previously shown weaker performance, rebounded sharply with sales more than doubling year-on-year.

Product portfolio diversification also drove performance. Sales of diagnostic products for vitamin D and anemia (Hemochroma) surged, resulting in over 140% growth in the “Other Conditions” category. Diagnostic kits for diabetes and hormonal disorders also posted growth exceeding 30%, while kits related to cancer and rheumatoid arthritis recorded notable gains.

The company’s diagnostic equipment segment continued to perform well, with over 3,200 new systems installed during Q1. More than 2,000 units of its flagship ichroma™ and AFIAS platforms, both equipped with multi-analyte functionality, were deployed. If this pace continues, annual installations could exceed 10,000 units, surpassing the pandemic-era average of approximately 9,000 units per year (2020–2021).

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

“We have prioritized quality enhancement across both diagnostic devices and cartridges. With our ongoing expansion into developed markets since 2023, quality competitiveness is no longer optional but essential. This aligns with the growing global demand for point-of-care testing in the post-COVID era, further strengthening our global presence.”

He added:

“2025 marks a pivotal year of transformation for Boditech Med, as we expand beyond immunodiagnostics into biochemistry, hematology, and veterinary diagnostics. We are accelerating our efforts to diversify our future business portfolio and reinforce our global strategy for sustainable growth.”

• 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.”