1. Tuberculosis remains one of the world’s deadliest infectious diseases, ranking among the top 10 causes of death globally and the leading cause from a single infectious agent. According to the WHO’s 2025 Global TB Report, there were an estimated 10.7 million incident cases in 2024, resulting in 1.23 million deaths (a mortality rate of 11.5%). [para. 1][para. 9] More than 20% of patients remain undiagnosed, with 2.4 million cases going undetected out of 10.7 million. [para. 10]
2. On June 16, The Global Fund to Fight AIDS, Tuberculosis and Malaria announced the rollout of a pioneering near point-of-care molecular diagnostic test for TB in 13 countries, including Bangladesh, Benin and Cameroon. The initiative will provide nearly 3 million rapid, highly accurate tests to previously underserved regions, with procurement valued at approximately $13 million. The testing solution is provided by Chinese biotechnology company Pluslife Biotech Co. Ltd. [para. 2]
3. Current TB diagnostic methods have significant limitations. Sputum smear microscopy is outdated and inaccurate; sputum bacterial culture is the gold standard but time-consuming; and emerging molecular diagnostics, while rapid and sensitive, require expensive equipment and specialized personnel, making them difficult to deploy in grassroots clinics. [para. 4] Pluslife’s new test addresses these issues by supporting tongue swab sampling, delivering results within one hour, and using compact, lightweight, battery-operated equipment suitable for clinics with unstable power supplies. [para. 5]
4. The test’s performance is validated by a global multicenter prospective study published in *The New England Journal of Medicine* in April 2025, involving 1,380 subjects across seven countries (India, Nigeria, the Philippines, South Africa, Uganda, Vietnam, and Zambia). The tongue swab test showed an overall sensitivity of 79.6% and specificity of 99.5%—about 18 percentage points higher in sensitivity than sputum smears, and roughly 9 percentage points lower than Cepheid’s Xpert Ultra, with comparable specificity. [para. 7][para. 17][para. 18]
5. The Gates Foundation played a key role in identifying and supporting Pluslife’s technology. In 2023, the foundation identified Pluslife’s solution; in 2024, Pluslife began developing the TB product with preliminary data, and the foundation funded small-scale testing at global partner clinical sites. Validated by large-scale clinical data published in top medical journals, the foundation continued supporting development, overseas trials, and WHO prequalification. [para. 13][para. 14][para. 15]
6. Pluslife’s innovation lies in its proprietary RHAM technology platform, which enhances the specificity and sensitivity of isothermal amplification—a method that operates at constant temperature, eliminating complex thermal cycling systems. This enables device miniaturization and lower cost. Additionally, the test does not require separate nucleic acid extraction; instead, samples are treated with a release agent and added directly to the amplification system, simplifying operation and reducing costs. [para. 21][para. 22][para. 23][para. 24]
7. Cost comparison highlights the advantage: Cepheid’s molecular diagnostic solution, holding over 80% market share, costs about $20,000 per instrument and $8–$10 per reagent, processing up to four samples. Pluslife’s instrument costs approximately $155, reagents about $3.60, testing one sample at a time. [para. 25] New TB cases are concentrated in 30 high-burden countries, with India (25%), Indonesia (10%), the Philippines (6.8%), China (6.5%), and others leading. [para. 27]
8. As the largest external funder in global TB, The Global Fund (73% of international TB financing) will continue supporting near point-of-care molecular testing over the next two to three years. The Children’s Investment Fund Foundation also committed an additional $50 million in September 2025 to accelerate innovative diagnostic tools. The Global Fund emphasized that this technology complements, not replaces, advanced platforms like GeneXpert, which remain critical for diagnosing drug-resistant TB. [para. 29][para. 30] Yang Min of the Gates Foundation noted the future upgrade path is detecting drug-resistant TB to guide precision treatment. [para. 31]
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