Breakthroughs Blog: Diagnostics

A new study led by the Harvard T.H. Chan School of Public Health found that Anopheles darlingi mosquitoes, a leading malaria vector in South America, are evolving resistance to insecticides, creating serious challenges for malaria control efforts in the region. Insecticide resistance has only been periodically documented in Anopheles darlingi populations, which have not been heavily targeted with insecticides for vector control, suggesting that some of the resistance may be driven by insecticides used in agriculture. The study is the first to sequence a large number of complete genomes of Anopheles mosquitoes in the Americas, looking at the genomic sequences for more than a thousand mosquitoes across six countries. The research provides a template for additional vector studies and paves the way for future studies that could help inform and improve malaria control efforts and policies to reduce the emergence and spread of dangerous resistant strains of the malaria parasite. Last week, Intelligenome announced that it has been awarded funding through a subaward agreement with Cornell University to develop a rapid, low-cost portable diagnostic test for tuberculosis (TB). The company will contribute its point-of-care testing platform to support the development of a portable, rapid assay capable of detecting TB in non-sputum respiratory and blood samples, which is designed specifically for low-resource settings. This approach integrates a CRISPR-based detection approach. The project is part of a program funded by the US National Institutes of Health aimed at improving access to innovative health technologies.Basilea recently announced that the first participant has been dosed in its first-in-human Phase 1 study of BAL2420, a novel antibiotic designed to treat serious bacterial infections. The antibiotic specifically targets infections, including drug-resistant infections, caused by bacteria in the Enterobacteriaceae family—that includes Escherichia coli and Klebsiella pneumoniae—which are considered high-priority threats for which new treatment options are urgently needed. BAL2420 is part of a novel class of antibiotics with a novel mode of action and has demonstrated promise in preclinical studies. Since 2020, BAL2420’s development has been supported by the Combating Antibiotic Resistant-Bacteria Biopharmaceutical Accelerator (CARB-X).  

A new real-world study found that a recently approved vaccine designed to reduce deadly meningitis in Africa is safe when used at scale. Neisseria meningitidis, or meningococcus, is a bacterium that is the leading cause of bacterial meningitis, a dangerous infection, in Africa. The African meningitis belt, which encompasses 26 countries in sub-Saharan Africa, has the highest rates of meningococcal disease, facing frequent epidemics. Since 2010, the introduction of a vaccine targeting one of the 12 bacterial strains has dramatically reduced meningitis in the region. The newer vaccine targets the five subtypes that are responsible for almost all epidemic meningitis in the region, and it was shown to be safe in a study analyzing data from more than 4.8 million people vaccinated during outbreak response campaigns in Nigeria and Niger in 2024. A research team has developed a breath-based test for diagnosing bacterial infections that showed promise in early studies in mice, which could eventually offer a non-invasive, portable, and quick alternative to the current toolbox of blood tests, imaging, cultures, and molecular diagnostics that can be slow, non-specific, and expensive. The researchers were inspired by a breath test for Helicobacter pylori, which works by a patient drinking a liquid containing traceable substances metabolized by H. pylori and then exhaling into a device that measures the components of their breath, indicating if an infection is present. Aiming to develop a breath-based test for a broader range of infections, the team developed a prototype using sugar and sugar alcohols tagged with a traceable form of carbon that bacteria metabolize but is not harmful to human cells, analyzing the breath using a simple technique. A team of researchers has designed a vaccine that turns mosquitoes into delivery vehicles to immunize bats against rabies and Nipah virus. Bats host a wide range of dangerous pathogens, which are increasingly spilling over into human and livestock populations. Researchers have previously tried testing experimental vaccines on captive bats, but the vaccines haven’t worked as effectively in the wild. Culling bat populations is another way to reduce disease transmission, but this can cause disruption to the ecosystem and can inadvertently heighten virus transmission by increasing human exposure. The new method involves an experimental vaccine that is delivered via the saliva of mosquitoes, which is transferred when bats eat the mosquitoes or the mosquitoes feed on the bats, directly targeting the natural reservoirs of these viruses to prevent spillover transmission. 

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 two-year citywide experiment in Singapore found that releasing Wolbachia-infected mosquitoes was effective at reducing mosquito numbers and dengue transmission in the densely populated city, supporting their use as a complement to existing vector control methods and vaccines to control transmission of dengue and other mosquito-borne diseases. Wolbachia is a common type of bacteria found in insects that cannot make people or animals sick but can stop the dengue virus from replicating inside the Aedes aegypti mosquitoes that spread dengue and other viruses, reducing mosquito populations and disease transmission. The researchers divided the city into clusters, releasing sterile infected male mosquitoes in some areas while leaving other areas untouched. They found that where the infected mosquitoes were released, mosquito numbers fell sharply, and people living there were about 70 percent less likely to develop symptomatic dengue after a few months of exposure. A Phase 4 randomized controlled trial has provided further evidence of the safety and efficacy of shortened regimens of preventive tuberculosis (TB), which could help improve uptake and completion rates. The trial, conducted in Brazil, tested one- and three-month regimens of isoniazid and rifapentine, much shorter than the current standard regimen of isoniazid, which lasts six to nine months and has seen poor uptake and completion rates. Additional studies are needed to ensure safety and acceptability across diverse populations. A Stanford University research team has developed an affordable, battery/solar-operated microscope called Octopi that uses artificial intelligence (AI) to automatically diagnose malaria in blood samples in minutes, which could greatly improve access to early and accurate diagnosis in low-resource settings. Confirmatory malaria diagnosis is currently done through a long, technical process carried out manually by lab technicians. The team also developed a complementary tool to automate and standardize the process of preparing blood samples, which is open source, requires no electricity, and is cheap.