Breakthroughs Blog: WHO

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 Despite major gains, access to WHO-recommended rapid tests has lagged, and many countries continue to depend on outdated diagnostic methods.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.

Newly shared results from a Phase 3 clinical trial found that a single-dose dengue vaccine was highly effective at preventing severe dengue, as the mosquito-borne disease continues to spread into new areas around the world. The vaccine, developed by the Butantan Institute in Brazil, was recently approved in Brazil for use in people aged 12 to 49 years old. The new trial found that among thousands of participants aged 2 to 59 years old, the vaccine was effective at preventing symptomatic dengue but especially effective—80.5 percent— at preventing hospitalization for at least five years. The World Health Organization (WHO) has shared new guidance highlighting critical targets for new antibiotics, as the global threat of antimicrobial resistance (AMR) continues to grow and outpace the development of new and innovative antimicrobials. The three areas outlined are the development of new drugs to fight Gram-negative bacteria that cause serious infections that are especially difficult to fight; new drugs for patients with serious infections that can no longer be treated with vancomycin, a powerful last-resort antibiotic; and new treatments for bacterial meningitis, which is getting harder to treat due to growing antibiotic resistance. While the research and development of a new antibiotics can be difficult, expensive, and not as profitable as other products, WHO aims to highlight key areas for investors and developers to focus their efforts to grow the pipeline of new, urgently needed tools. Last week, the Sabin Vaccine Institute announced that it has completed enrollment in six Phase 2 clinical trials for its Marburg and Sudan Ebolavirus vaccines in Kenya, Uganda, and the United States, as increasing outbreaks of both viruses in recent years have highlighted the urgent need for vaccines. There are currently no licensed vaccines for protection against the highly contagious, life-threatening diseases caused by these viruses. The Marburg vaccine has also been evaluated during recent outbreaks in Rwanda in Ethiopia. Both candidates have so far demonstrated strong safety and efficacy profiles. The Sabin Vaccine Institute has also begun planning larger Phase 3 trials for each of the vaccines. 

The World Health Organization (WHO) stands at a crossroads—one that could redefine its role in global health and reshape the global health research and development (R&D) ecosystem. In 2025, WHO faced a tumultuous year as several member states—including the United States and Argentina—moved to step back from the organization, citing concerns over its early COVID-19 response and broader calls for reform. These withdrawals, coupled with unpaid dues, have exacerbated existing budget shortfalls and triggered a sweeping restructuring effort aimed at slimming budget and operations, reorganizing leadership, and overhauling the organization’s structure. Yet, how these parallel developments—member states’ retreat and WHO restructuring—are being managed by the health organization remains remarkably opaque. Decisions have unfolded largely behind closed doors, leaving researchers, product developers, regulators, and advocates struggling to understand where responsibilities now sit, how coordination is continuing—or not—and what critical functions may be falling through the cracks. Though WHO leadership has continued to express hope that the United States would reconsider its withdrawal, it is also unclear to what degree informal coordination between these two actors may continue, underscoring the uncertainty facing global health R&D at a moment when clarity and coordination are most needed.WHO plays an irreplaceable role in supporting global health R&D, from setting research priorities and supporting regulatory convergence to coordinating disease surveillance and establishing norms that guide research. As WHO restructures and member states withdraw, these R&D functions risk erosion, creating gaps that could slow innovation, weaken outbreak preparedness, and undermine access to essential health, including both worldwide and in the United States. This blog explores what’s at stake and the unanswered questions that remain. Function at risk: Technical and coordinative support for regulatory bodiesWHO’s research coordination role is reinforced—and amplified—through its technical and convening support for national and regional regulatory authorities. Argentina’s National Administration of Medicines, Food, and Medical Technology (ANMAT), for example, has been recognized by the Pan American Health Organization (PAHO)—WHO’s regional arm for the Americas—as a gold standard Regional Reference Regulatory Authority since 2011. In this capacity, ANMAT has advanced regulatory convergence, capacity-building, and reliance mechanisms across the Americas. Argentina’s retreat from WHO- and PAHO-led regulatory collaboration risks weakening a critical pillar of regional regulatory trust, slowing approvals of quality-assured medical products, and reducing timely access to medicines for patients throughout the region.Beyond regional leadership, WHO’s technical and regulatory functions are tightly linked to how countries approve and adopt new health technologies. Through its prequalification process, which relies on assessments performed by stringent authorities such as the US Food and Drug Administration (FDA), WHO helps countries by assessing product quality, safety, and efficacy more efficiently. In turn, WHO also has come to rely on technical expertise from the FDA and other national regulators. Weakening this symbiotic relationship risks slowing the global uptake of FDA-approved products, diminishing incentives for US innovators to invest in neglected diseases and pandemic threats, and delaying patient access to safe, effective, and affordable health technologies worldwide.  What’s at stake: With WHO’s role as a global regulatory harmonizer in question, will we see an increasingly fragmented regulatory landscape—slowing approvals, duplicating effort, and delaying access to lifesaving products for patients who need them most?  Function at risk: Setting research priorities for clinical and product development WHO convenes scientists, funders, and governments to set global research priorities, align investments, and streamline clinical trials—especially during public health emergencies. This coordination is critical to accelerating the development of vaccines, diagnostics, and treatments for diseases such as HIV, tuberculosis, malaria, and emerging pathogens. In particular, WHO’s development of target product profiles provides an evidence-based roadmap for product developers, helping ensure that new tools meet public health needs, are fit for use in diverse settings, and can interrupt outbreaks before they escalate. Diminishing WHO’s capacity could slow progress across these areas. Efforts may become fragmented or duplicative, and delays could ripple through the R&D pipeline—postponing the availability of lifesaving innovations. In an interconnected global economy, such delays affect all nations by heightening health risks and disrupting supply chains, and they could ultimately impose economic costs on the United States. What’s at stake: If WHO’s R&D programs are undermined, how will global research priorities be aligned and by whom? How will we ensure that scarce R&D resources are prioritized and coordinated to target the most urgent health threats?Function at risk: Disease surveillance and monitoring systems WHO coordinates some of the world’s most critical disease surveillance networks, including the Global Influenza Surveillance and Response System, which informs the development of the flu vaccines used by people around the world, including Americans. Budget cuts, staff reductions, and program relocations could threaten the speed and reliability of outbreak detection, data sharing, and global coordination, making it harder to identify and respond to emerging threats before they spread internationally. Member states that remove themselves from WHO-coordinated surveillance programs put themselves at risk as emerging outbreaks could cross borders and reach countries such as the United States or Argentina before national health authorities have early visibility. What’s at stake: If WHO's disease surveillance programs are hollowed out by member state withdrawals, to what degree will gaps in data and early warning signals delay vaccine development and leave the world less prepared for the next pandemic? Amid sweeping changes at WHO and the growing implications of member state withdrawals, vital questions remain around how and whether WHO can preserve its vital role in the R&D ecosystem. Moreover, there remains little clarity on how the United States and WHO will manage this transition, where critical gaps are already forming. We can look back to the COVID-19 pandemic and see that global health R&D moves faster and more effectively when countries align around shared priorities, pool evidence, and coordinate trials—functions WHO is uniquely positioned to lead. This lack of clarity creates risk: for global health R&D, for outbreak preparedness, and for American health security. WHO will continue its core governance and policy processes in 2026, beginning with its next Executive Board meeting in February. These moments must be used by the global health community to demand greater transparency amid sweeping institutional shifts and to continue pressing for sustained investment in R&D functions that cannot afford erosion. Put simply, if we don’t know what is being scaled back, restructured, or deprioritized, we cannot ensure that the systems that move health innovations from labs to patients remain protected. 

Last week, the Global Antibiotic Research & Development Partnership (GARDP) and Debiopharm announced a new partnership to advance the development of Debio1453, a novel, first-in-class antibiotic targeting Neisseria gonorrhoeae, as rising cases and the continued spread of multidrug-resistant strains have turned gonorrhea into a growing health challenge globally. Almost all the antibiotics used to treat gonorrhea caused by N. gonorrhoeae have been rendered ineffective due to antimicrobial resistance, with the bacteria now beginning to develop resistance to the last remaining effective treatment. If successful, this drug candidate could help revive the critically lacking pipeline of new antibiotics, one of many new drugs that will be needed to ensure that innovation can outpace the rapid emergence of antibiotic resistance.  Sedia Biosciences announced last week that the World Health Organization (WHO) has granted prequalification status for its rapid, oral HIV test, enabling global procurers to buy the test and ensure widespread access to the technology. The single-use test, which detects antibodies to HIV-1 and HIV-2 in as little as 20 minutes, is intended for health care providers to be able to use at the point of care in resource-limited settings. Beyond its rapid readout time, the test is less invasive, complicated, and painful than blood testing because it uses oral fluid (saliva), making it simpler and more tolerable for patients. With support from the Coalition for Epidemic Preparedness Innovations (CEPI), the Serum Institute of India and the University of Oxford are partnering to create the largest-ever reserve of an investigational vaccine for Rift Valley fever, against the backdrop of a deadly ongoing outbreak and the threat of future outbreaks of the disease, for which there are no licensed human vaccines. The Serum Institute will manufacture up to 100,000 doses of the University of Oxford’s ChAdOx1 RVF candidate, which is among the most advanced investigational vaccine candidates in the pipeline. Ten thousand doses are set to be used in a planned clinical trial of the candidate in outbreak-affected areas, while the remaining doses will serve as a reserve available for clinical testing during future outbreaks.