SD Biosensor Listed in WHO's Official Recommendation, Strengthening Its Global Leadership in Latent Tuberculosis Testing

Original from: PR Newswire

SD Biosensor, Inc. (KQ137310), a global leader in in-vitro diagnostics from South Korea, announced that its latent tuberculosis (TB) diagnostic product, STANDARD E TB-Feron ELISA (hereafter STANDARD TB-Feron), has been officially included in the World Health Organization (WHO) recommendation list for TB diagnostics. With this milestone, SD Biosensor strengthens its position in the Interferon-Gamma Release Assay (IGRA) market, marking a shift in the competitive landscape and positioning the company alongside leading global players.

According to the WHO Operational Handbook on Tuberculosis (Module 3: Diagnosis), an estimated 25% of the global population is infected with Mycobacterium tuberculosis in a latent tuberculosis state. In 2023, there were an estimated 10.8 million new cases of active tuberculosis worldwide. While active tuberculosis can be transmitted to others through coughing or sneezing, latent tuberculosis is non-infectious, as the bacteria remain inactive in the body. However, individuals with weakened immune systems are at risk of developing active tuberculosis, making early screening and treatment essential. The WHO recently reported that tuberculosis may have surpassed COVID-19 as the leading cause of death from a single infectious disease, further underscoring the urgent global need to eliminate tuberculosis. As of 2024, the latent tuberculosis diagnostics market is valued at an estimated USD 582.5 million and is projected to grow at a compound annual growth rate (CAGR) of 5.8% through 2029.

The recent inclusion of STANDARD TB-Feron in the WHO list of recommended diagnostic tests marks a significant milestone, as this list serves as a key reference for public health authorities, international health organizations, NGOs, and medical institutions worldwide when adopting diagnostic products. This inclusion affirms the product's technical excellence and clinical reliability, increasing the likelihood of its adoption at the national level. Being listed also plays a crucial role in easing entry barriers into overseas markets by giving the product priority consideration in global procurement programs and international tenders. This achievement follows the WHO Technical Advisory Group (TAG) meeting held in January 2025, during which STANDARD TB-Feron underwent a Pathway B evaluation and was recognized as delivering performance comparable to existing WHO-recommended test kits.

The WHO currently recommends three types of tuberculosis diagnostic tests: ▲the tuberculin skin test (TST), ▲the TB antigen skin test (TBST), and ▲the interferon-gamma release assay (IGRA). In particular, IGRA testing enables accurate diagnosis irrespective of a patient's BCG vaccination history and allows simultaneous analysis of multiple samples. Compared with skin tests such as TST and TBST, which require patients to return after 2–3 days, IGRA offers a simpler testing procedure, broader applicability and more rapid test results, making it especially effective for fast and efficient diagnosis in high tuberculosis-burden countries.

Based on the IGRA method, SD Biosensor's STANDARD TB-Feron streamlined testing by requiring only three sample tubes, compared to the four used in conventional commercial products, enabling the processing of more samples at once and making it well-suited for large-scale screening. In addition, the required blood volume has been reduced to 3 mL, reducing patient discomfort and lowering the risk of operator error. The total testing time is also shortened by about one hour, significantly enhancing speed and efficiency, while the open-reagent design ensures compatibility with a wide range of laboratory equipment used in different countries. Another key feature is the use of TB-specific antigens, which provide high sensitivity and specificity, ensuring accurate results.

Serena Cho, Executive Vice President of SD Biosensor, stated, "The inclusion of STANDARD TB-Feron in the WHO's official list of recommended diagnostics is both a testament to the product's outstanding performance and reliability, and a symbolic milestone that marks SD Biosensor's position as a global leader in latent tuberculosis diagnostics. Our technology combines accuracy and efficiency, making it ready for immediate integration into national TB elimination programs worldwide. STANDARD TB-Feron is already registered and approved in key markets, and with this WHO recommendation, we are confident that adoption by global health authorities and international organizations will further accelerate." Cho added, "Building on this achievement, we will expand our supply chain in Europe, the Middle East, and other regions with a high tuberculosis burden to increase market share and drive significant revenue growth."

Source: SD Biosensor Listed in WHO's Official Recommendation, Strengthening Its Global Leadership in Latent Tuberculosis Testing