Breakthroughs Blog: Diagnostics

A team of researchers from the United Kingdom, the United States, and South Africa is developing a vaccine for hantavirus, the virus behind a worrying outbreak on a cruise ship in the Atlantic Ocean. Hantavirus is typically spread by rodents, and transmission between humans is very rare. There is no specific treatment of vaccine for hantavirus, which, as seen in the current outbreak, can be deadly. The researchers are using an innovative method called insilication to make the vaccine thermally stable, aiming to reduce the high resource and economic costs of meeting the cold chain and storage requirements that are associated with many vaccines. Moderna’s mRNA-based seasonal flu vaccine outperformed conventional flu shots in a late-stage international trial of more than 40,000 adults aged 50 and older. The US Food and Drug Administration is currently reviewing the vaccine after rejecting the initial application and is expected to make a decision by August 5. If approved, the vaccine would be the first mRNA seasonal flu shut in the United States. mRNA vaccines can be produced much more quickly than conventional flu shots, which could enable public health authorities to wait longer before choosing which flu strains to target, giving them more time to gather up-to-date data about circulating strains before flu season begins. A research team has discovered a previously unknown mechanism by which HIV-1 can infect resting cells, challenging previous assumptions and raising new possibilities for the development of improved treatments. For HIV to infect immune cells, it must deliver its genetic material into the cell’s nucleus, which is surrounded by a protective structure—how the virus has broken through the barrier has long puzzled scientists. Another obstacle to an HIV cure has been the latent reservoir of resting immune cells that house dormant virus, which cannot be cleared by treatment. The researchers found that when the virus spreads between immune cells, it triggers a signal that unlocks this protective gateway around the nucleus, allowing the virus to enter. They also found that this process does not require the immune cell to be activated, meaning that the reservoir can be established and maintained while cells are resting, upending long-standing assumptions and unlocking new avenues toward the development of a treatment that can destroy the virus and target the latent reservoir. 

A new US National Institutes of Health-funded study conducted in seven high tuberculosis (TB)-burden countries found that a new and improved near point-of-care TB test platform was highly accurate, effective, and scaleable. Pluslife Biotech’s MiniDock MTB test platform is battery operated, low-cost, provides results in 30 minutes, and can be used with tongue swabs in addition to sputum samples, which certain groups, including babies and people living with HIV, cannot produce. The new test is well-suited for low-resource, smaller, or more rural health clinics, which may not have access to current resource-intensive, expensive molecular testing options. The University of Oxford and the Serum Institute of India have signed a license agreement to support the development, large-scale manufacturing, and potential future commercialization of the malaria vaccine candidate R78C for use in clinical settings. R78C combines two Plasmodium falciparum blood-stage antigens, designed to target the malaria parasite at multiple points in its lifecycle, offering longer and more effective protection. This new license, which builds on a long-standing collaboration between the partners on malaria vaccine work, will initially help accelerate the candidate into clinical evaluation. The Serum Institute of India’s global manufacturing capabilities will also help ensure that resulting successful malaria vaccines can be manufactured at scale and deployed affordably to malaria-endemic countries. The Medicines for Malaria Venture (MMV) and Novartis recently announced that the World Health Organization (WHO) has prequalified Coartem® Baby, the first and only antimalarial drug developed specifically for newborns and young infants weighing between 2 and 5 kilograms. This treatment will help address a long-standing gap in malaria care for this group, who are often treated with antimalarial formulations intended for use in older children, which can increase the risk of toxicity or underdosing. The prequalification designation enables countries and global procurers to start purchasing and deploying the treatment in malaria-endemic countries; Novartis is making the treatment available on a largely nonprofit basis in malaria-endemic regions. 

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.