Breakthroughs Blog: Tuberculosis

A new study from a research team at Houston Methodist found that a new AI-powered tool could help accelerate the development of treatments targeting antibiotic-resistant bacterial pathogens, as the global threat of antimicrobial resistance continues to grow. The AI-based platform integrates machine learning with biologically informed features to evaluate and rank libraries of candidate peptides—small proteins that are part of the body’s immune system—based on their potential to address these bacterial pathogens. The researchers used the platform to identify a promising candidate peptide that demonstrated an ability to effectively target methicillin-resistant Staphylococcus aureus (MRSA) at low concentrations in lab tests.  Last week, the Coalition for Epidemic Preparedness Innovations and the Pan American Health Organization (PAHO) announced an expanded collaboration to strengthen regulatory systems and pharmacovigilance programs across Latin America and the Caribbean, supporting rapid, equitable access to safe vaccines, including during pandemics. Specifically, the funding will support workforce training, enhanced collaboration among national regulatory authorities, and regulatory capacity-strengthening, enabling more efficient and aligned pathways toward the evaluation and approval of safe and effective vaccines during outbreaks. This collaboration builds on a broader partnership, first forged in 2024.  A Phase 3 trial conducted in India found that two tuberculosis (TB) vaccine candidates did not show efficacy against all forms of TB, including pulmonary TB and latent TB, but they did demonstrate safety and offer limited protection against a more severe form of the disease. The PreVenTB trial, led by the Indian Council of Medical Research, evaluated the efficacy of VPM1002 and Immuvac, which represent 2 of the 16 vaccine candidates in the pipeline for TB aiming to become the first new vaccine for TB in more than 100 years. The only current licensed offers inconsistent protect against pulmonary TB in adults. 

Fifteen years ago, the World Health Organization (WHO) issued formal guidance recommending the first WHO-endorsed rapid test for tuberculosis (TB), a landmark shift for a diagnostic landscape that had long relied on slow, labor-intensive microscopy and culture methods. For the first time, high-quality, same-day diagnosis could be possible for millions.Yet the promise of this breakthrough remains only partially realized. Despite major gains, access to WHO-recommended rapid tests has lagged, and many countries continue to depend on outdated diagnostic methods. In 2024, more than 8.3 million people were newly diagnosed with TB, but only around half of them were diagnosed with a WHO-recommended rapid diagnostic test as their initial test. Even more troubling, an estimated 2.7 million people around the world who develop TB remain undiagnosed and untreated.These persistent gaps point to a clear imperative: countries and global health partners must both accelerate access to existing rapid diagnostics and continue investing in the next generation of TB diagnostic tools designed for real-world settings. A new wave of innovative, accessible tools, including a recently recommended class of near point-of-care molecular tests and an emerging generation of digital and artificial-intelligence (AI)-powered screening tools, is now materializing, offering renewed opportunities to close the diagnostic gap for good.New class of near point-of-care diagnostic testsIn early 2026, WHO recommended a new class of near point-of-care tests, nucleic acid amplification tests (NPOC-NAATs), representing one the most significant advances in TB confirmation diagnosis in more than a decade. These molecular tests can detect TB in less than an hour using lightweight, battery-operated instruments that do not require specialized infrastructure for use or storage, making them easily portable. They can be used by health care workers with minimal training in primary health care clinics, mobile units, or community sites, bringing high-quality molecular testing closer to patients, dramatically shortening the time to diagnosis and treatment initiation, and reducing loss to follow-up.WHO now recommends NPOC-NAATs as the initial test for adults and adolescents with symptoms of pulmonary TB or a positive screening result, replacing smear microscopy, which involves the lengthier, more complex and resource-reliant process of collecting sputum (phlegm) samples and preparing them for examination under a microscope in a laboratory. Crucially, WHO also endorsed the use of tongue swabs when sputum samples cannot be collected, improving access for children, people living with HIV, and others who may struggle to produce sputum, who were underserved by previous options.A major milestone came in July 2025, when PlusLife’s MiniDock MTB assay became the first of this class approved by The Global Fund to Fight AIDS, Tuberculosis and Malaria’s Expert Review Panel for Diagnostics, making it eligible for procurement by Global Fund-supported programs. In early 2026, the Stop TB Partnership’s Global Drug Facility announced it would add the test to its portfolio at a low price, further accelerating global access.Additional NPOC-NAAT approvals are expected, which would increase the range of options for patients and drive down prices for governments and procurers, enabling countries to implement these technologies at scale. If widely adopted, NPOC-NAATs could dramatically expand access to high‑quality TB diagnostics, especially in rural and underserved areas where TB can go undetected.Growing number of digital and AI-powered screening toolsJust as a new class of molecular tests are reshaping TB diagnosis, a new generation of digital and AI-enabled devices are transforming TB screening, the essential first step that identifies potentially impacted people who need confirmatory testing. Over the past decade, rapid advances have enabled the development of innovative screening tools that are faster, more accessible, and better suited to the realities of remote and low-resource settings.Portable, battery-operated radiology devices are one tool that has emerged, with various commercial products starting to be rolled out at a larger scale in recent years. These devices can be brought directly to remote communities, improving screening access for hard-to-reach populations.In areas where radiology remains inaccessible, portable, point-of-care ultrasounds are another promising, low-cost solution for TB detection in low-resource settings. The Butterfly iQ portable ultrasound device is currently being evaluated in a large trial in sub-Saharan Africa, where it is being used alongside an AI algorithm that automatically classifies TB-related abnormalities in images captured by the device, helping health care workers faster and more accurately detect TB at the point of care.AI-powered computer-aided detection software has also advanced rapidly, with a growing range of commercial products in recent years. These tools automatically analyze and interpret chest X-rays to identify potential TB cases, expanding the reach and speed of screening programs. Since first recommending AI as a TB screening tool for adults in 2021, WHO has approved six software products for computer-aided detection.Digital stethoscopes are another AI-powered tool—they analyze lung sounds to rapidly screen for pulmonary TB, a solution that can be deployed in community and primary care settings, even by workers without specialized training. AI Diagnostics’ stethoscope and software platform captures high-resolution lung sound recordings and analyzes them using machine learning models, generating a screening result that allows health care workers to distinguish individuals at higher risk of TB. The device is approved in South Africa and is starting to be rolled out more widely.Looking forwardAs TB program budgets globally face growing financial pressures, it is more important than ever to phase out outdated technologies and rapidly scale up next-generation diagnostic tools engineered for broad accessibility. These innovations now emerging, including near point-of-care molecular tests and digital and AI-powered screening tools, represent a pivotal opportunity to close the longstanding diagnostic gap and strengthen TB care pathways.Alongside these efforts, sustained investment in the robust pipeline of new TB diagnostics is also essential to driving continued progress, particularly for solutions that remain understudied: diagnostics tailored for children and other vulnerable populations and treatment monitoring tools to help tailor regimens for people at risk of poor outcomes.With deliberate action and continued innovation, the global community can deliver a better diagnostic ecosystem that meets people where they are and ensures that no one with TB goes undiagnosed or untreated.

A research team has identified a protein in the malaria parasite that could offer a promising new target for antimalarial drug development. The researchers found that the protein Aurora-related kinase 1, or ARK1, is essential for the survival and transmission of the malaria parasite. When the researchers turned it off in the lab, the parasite could no longer replicate or complete its development in either humans or mosquitoes, effectively stopping its ability to transmit disease. The ARK1 in malaria parasites is also very different from the version found in human cells, meaning drugs designed to target the protein could be effective without causing harm to humans.  A Phase 3 trial found that a novel single-tablet combination treatment regimen for HIV provided similar viral suppression compared to a multi-pill therapy in older adults, a significant step toward a simpler option for patients who cannot use currently available single-table regimens. The trial included older adults living with HIV who had sustained viral suppression and long treatment histories and remained on complex regimens because of prior drug resistance, intolerance, or other factors that made single‑tablet options unsuitable. The single-tablet regimen was not only similarly effective, but it was also associated with increased treatment satisfaction, as well as improvements in cholesterol and triglyceride levels. Last week, IAVI announcedthat a large Phase 2b trial of the tuberculosis (TB) vaccine candidate MTBVAC will expand to include a new cohort of 1,200 patients who have never been exposed to the Mycobacterium tuberculosis bacterium that causes TB disease. The additional cohort will enable researchers to gather robust safety and immunological data across patients with and without confirmed previous TB infection, increasing understanding of how the vaccine works across diverse populations. MTBVAC is a single-shot vaccine designed to be accessible in remote and low-resource settings; it’s also the only live-attenuated candidate derived from M. tuberculosis currently in trials.

A Phase 2 trial in The Gambia found that a vaccine for enterotoxigenic Escherichia coli (ETEC), a leading cause of diarrheal disease in children in low-income countries, was safe and effective in children between 6 and 18 months old. Cases of ETEC are expected to increase in the coming years due to climate change, and the vaccine under study, ETVAX, the most advanced of the several ETEC vaccines in the pipeline, could help reduce illness and death, lower health care costs, and curb the growing threat of antimicrobial resistance. The vaccine will now advance to a large multicountry Phase 3 trial for further evaluation. A research team at the University of Buffalo has developed an inhalable drug-delivery system for treating tuberculosis (TB), which could reduce the frequency of dosing and lessen side effects. Standard treatment for TB can be lengthy and require multiple drugs, with unpleasant side effects, leading some patients to stop treatment— contributing to the emergence of drug-resistant TB. The new approach involves an inhalable nanoparticle system that modulates the immune system and carries rifampin, a common TB drug, directly to the lungs, where TB bacteria primarily reside. This targeted method contrasts with the pill formulation of rifampin, which, when taken orally, only delivers limited amounts of the drugs to lung tissue. Further studies will explore whether the nanoparticle system can deliver combination treatments, which are the cornerstone of TB treatment, and whether the system can be adapted to address other lung diseases. Ghana recently became the first-ever country to approve a new single-dose combination treatment for soil-transmitted helminths, which cause parasitic infections that affect millions in endemic regions in Africa. The regimen is as safe as the standard drug used in mass deworming campaigns and demonstrates improved efficacy against whipworms, which are often resistant to the single-drug treatment. The medicine is also fruit-flavored, fast-dissolving, and incorporates a novel age-based dosing strategy, making it suitable for children. Administering the two drugs incorporated in the combination treatment previously required between two and six pills per person.