QIAGEN
QIAGEN N.V. is a global provider of sample and assay technologies, with a strong presence in molecular diagnostics and a leading position in the latent TB testing market through its flagship QuantiFERON franchise. The company’s core offering, the QuantiFERON-TB Gold Plus (QFT-Plus), is a next-generation interferon-gamma release assay (IGRA) that is FDA-approved and WHO-authorized. QFT-Plus is a high-specificity blood test that indirectly detects latent TB infection by measuring the T-cell immune response to specific Mycobacterium tuberculosis antigens, notably ESAT-6 and CFP-10. This test is favored because it is unaffected by prior Bacillus Calmette-Guérin (BCG) vaccination, a major limitation of the traditional tuberculin skin test (TST). QIAGEN consistently drives innovation in this segment, as evidenced by the test’s certification under the EU’s IVDR. By continuously focusing on integrating its assay with workflow automation and offering a user-friendly, single-visit diagnostic solution, QIAGEN maintains its competitive advantage and plays a crucial role in enabling large-scale, accurate latent TB screening worldwide.
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Revvity
Revvity, Inc. is a leading health science solutions company that plays a pivotal role in the latent TB market, particularly through its acquisition of Oxford Immunotec, the developer of the T-SPOT.TB test. T-SPOT.TB is an ELISPOT-based IGRA, which is the sole such test to have received FDA approval, distinguishing it from ELISA-based IGRAs. The test is highly valued for its performance in immunocompromised patients and for delivering fewer indeterminate results due to its cell number normalization step. Revvity continues to advance the test’s efficiency; in early 2025, the company received FDA approval for the integration of its Auto-Pure 2400 liquid handling platform with the T-SPOT.TB test. This automation provides a high-throughput solution that significantly streamlines laboratory workflows, allowing mid-to-high-volume reference laboratories to process up to 24 samples per run in under 3.5 hours. Revvity’s strategic focus is on delivering accurate, scalable, and automated diagnostic solutions to accelerate the global effort to fight infectious diseases.
F. Hoffmann-La Roche Ltd
F. Hoffmann-La Roche Ltd (Roche) is a global healthcare giant leveraging its extensive diagnostics division to maintain a significant presence in the tuberculosis and latent TB testing market. Roche Diagnostics provides advanced, automated molecular and immunological solutions that support both active and latent TB detection. The company’s strategy involves integrating high-throughput, automated platforms that are critical for processing large volumes of patient samples quickly and accurately, particularly in centralized laboratories and major hospital networks. Roche’s involvement extends to continuous innovation in the diagnostic space, exemplified by its 2024 acquisition of LumiraDx, which signals a move to potentially expand its offerings into lateral-flow and point-of-care formats. By enabling faster turnaround times and more efficient, high-quality sample analysis, Roche supports personalized diagnostics and therapeutic monitoring, contributing significantly to enhanced surveillance and management of latent TB on a global scale.
bioMérieux
bioMérieux is a French company specializing in *in vitro* diagnostics, providing solutions for clinical and industrial applications, and is a key player in the latent TB detection market. The company develops and markets the VIDAS TB-IGRA test, an Interferon-Gamma Release Assay that is part of its comprehensive VIDAS immunoassay testing range. Recognizing the demand for efficient, scalable laboratory solutions, bioMérieux announced the CE-marking of its next-generation automated immunoassay system, VIDAS KUBE, in late 2022. This desktop system is designed to provide clinical labs with a streamlined, automated workflow for a broad test menu, including latent TB testing. By focusing on integrated systems that can deliver rapid and reliable results, bioMérieux helps to speed up patient care and improve diagnostic efficiency in hospital and clinical settings, making latent TB screening more accessible and less prone to manual error.
SD Biosensor, INC.
SD Biosensor, INC. is a South Korean in-vitro diagnostics company that has become a globally recognized force in the latent TB testing market, primarily through its STANDARD E TB-Feron ELISA product. This assay is an ELISA-based whole-blood IGRA, and its significance was underscored in August 2025 when it was officially included in the World Health Organization (WHO) recommendation list for TB diagnostics. This WHO endorsement recognizes the product’s high-performance and clinical reliability, positioning it for wider adoption by international organizations and health authorities globally. A key technological advantage of the STANDARD E TB-Feron is its innovative 3-tube design, which reduces the required blood volume compared to conventional 4-tube products. This feature enhances the test’s speed and efficiency, making it particularly well-suited for high-throughput and large-scale screening programs in high-burden countries.
Beijing Wantai Biopharmaceutical Co., Ltd.
Beijing Wantai Biopharmaceutical Co., Ltd. is a major Chinese diagnostics manufacturer with a prominent position in the latent TB testing market. The company is specialized in the diagnosis of infectious diseases and leverages a strong foundation in enzyme immunoassay (ELISA), chemiluminescence (CLIA), and nucleic acid diagnosis. As one of the key players profiled in the market, Beijing Wantai contributes by developing and manufacturing a range of diagnostic tests that are essential for latent TB screening. Its focus on strong, focused R&D activities and its established presence in the Chinese market—which is home to a significant global TB burden—provides a robust platform to address the growing demand for effective and reliable testing solutions. By offering diverse testing formats, the company supports national health initiatives aimed at detecting latent TB infection to prevent its progression to active disease.
Lionex GmbH
Lionex GmbH is a German company known for its work in diagnostics and therapeutics, and it is identified as a key developer and provider of latent TB testing solutions. The company offers the LIOFeron TB/LTBI IGRA, an ELISA-based whole-blood interferon-gamma release assay. This product falls into the dominant technology platform of ELISA-based IGRAs, which are widely adopted by diagnostic laboratories for their high-throughput capabilities, established quality-control procedures, and cost-effectiveness compared to other methods. As a specialized diagnostics firm, Lionex supports the global effort to control TB by providing a robust and reliable test that aids clinicians and public health agencies in the accurate diagnosis of latent tuberculosis infection. Its continued presence in the competitive landscape reinforces the importance of diverse, high-quality IGRA options for both routine screening and complex diagnostic scenarios.
Sanofi
Sanofi is a major French multinational pharmaceutical and healthcare company that is profiled as a key participant in the global latent TB testing market. While primarily known for its extensive portfolio of vaccines and therapeutic drugs for various diseases, Sanofi’s involvement in latent TB diagnostics is strategic, leveraging its global distribution network and regulatory expertise. Its presence in the market is typically associated with the development, manufacturing, and distribution of testing components or integrated solutions, potentially including diagnostic reagents or collaborating on the development of new screening technologies. As a key player, Sanofi’s contribution is vital in improving the affordability, accessibility, and supply chain reliability of latent TB tests, supporting large-scale public health programs and ensuring that essential diagnostics reach high-burden and low-resource settings around the world.
Thermo Fisher Scientific Inc.
Thermo Fisher Scientific Inc. is a globally renowned supplier of scientific instruments, consumables, and software services, and it plays a critical role in the latent TB testing ecosystem. While not always cited for a single flagship IGRA product, the company’s molecular and diagnostic platforms are foundational for high-throughput TB screening. Thermo Fisher provides the instruments and reagents essential for advanced molecular assays, such as qPCR and automated sample processing systems. These technologies enable rapid, high-accuracy detection and are used extensively in reference laboratories to support both active and latent TB diagnostics. By offering robust, user-friendly, and scalable infrastructure, including those for nucleic acid amplification and digital PCR, Thermo Fisher empowers research and clinical labs to manage high volumes of tests efficiently, thereby making a critical contribution to the overall speed and quality of latent TB detection globally.
ARKRAY, Inc.
ARKRAY, Inc. is a Japanese company specializing in the development and manufacture of clinical testing instruments, reagents, and diagnostic systems, securing its position as a key company in the latent TB testing market. The company’s focus is generally on providing systems that are accurate and easy-to-use for both centralized laboratories and point-of-care settings. In the context of latent TB, ARKRAY’s role involves offering diagnostic test kits or platforms that support the identification of *Mycobacterium tuberculosis* infection. By developing reliable diagnostic tools, ARKRAY contributes to the enhancement of public health measures, particularly in regions where efficient and accessible testing is crucial for controlling the spread of the disease. The company’s commitment to quality diagnostic products helps healthcare providers worldwide in implementing effective screening and intervention strategies for latent TB.
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