Breakthroughs Blog: Diagnostics

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. Newly published research suggests that a patient-centered approach, combining novel diagnostic tools with targeted therapies, could be a game changer in tuberculosis (TB) treatment. Current TB treatment requires a complicated, months-long regimen that can be hard for patients to adhere to, leading to treatment failure and the emergence of drug-resistant TB strains. The researchers behind the new study suggest that new diagnostic tools that can better distinguish between patients with less and more severe forms of TB combined with, respectively, shorter or longer, more resource-intensive treatment courses could improve patient outcomes, reduce the burden on health systems, and limit the emergence of drug resistance.Last week, Bavarian Nordic announced the start of the first of two clinical trials testing the use of its Jynneos mpox/smallpox vaccine in vulnerable populations, including infants and children two years old and younger and pregnant or breastfeeding women. If the vaccine demonstrates safety and efficacy, the trial data could help support expanded access to the vaccine for the most vulnerable populations. The trial is being led by the University of Antwerp and the University of Kinshasa and supported financially by EDCTP3 and the Coalition for Epidemic Preparedness Innovations.A recently published study found that a single-dose, long-lasting flu drug could provide protection for an entire flu season, offering longer and more effective protection than our current seasonal flu vaccines. The clinical trial followed 5,000 healthy adults for the entire duration of the most recent flu season, finding that the highest dose of the drug provided more than 76 percent protection compared with a placebo shot. The drug has also demonstrated efficacy against a wide variety of flu strains in a previous study in mice, compared to the season influenza vaccines, which are designed (prior to flu season based on expert assumptions) to protect against at least three of the seasonal strains that circulate each season and whose efficacy depends on how well they match the flu strains that end up circulating.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. Last Wednesday, Gilead announced that its twice-yearly injectable drug for HIV prevention has received approval from the US Food and Drug Administration, the first and only such shot for HIV prevention. The drug, lenacapavir, which is already used to treat HIV in certain populations, was found to dramatically reduce the risk of infection, providing near total protection among cisgender men and women, transgender men and women, and nonbinary people in clinical trials. The twice-a-year injection offers a significant improvement over current HIV prevention options that require a daily pill or every two-month injections, helping improve uptake and adherence by providing a more discreet, private, and less cumbersome alternative. Pricing and access plans for the United States and the rest of the world will determine the scale of lenacapavir’s impact on the broader HIV epidemic.Researchers from Cornell University have found that the antibiotic rifampin, which is already widely used, is 99.9 percent effective against Salmonella Typhi, the bacterium that causes typhoid fever, which a growing threat due to antibiotic resistance. The researchers found that S. Typhi is still highly susceptible to the antibiotic and that rifampin-resistant typhoid is extremely unlikely to emerge, despite concern due to the previous emergence of rifampin-resistant tuberculosis cases. The researchers found that rifampin may also be effective against other life-threatening diseases like bacterial pneumonia and meningitis.Newly published research found that a simple, affordable device made with strips of paper was more effective than other commonly used testing methods at detecting malaria in asymptomatic people in Ghana. Malaria testing, particularly at the point of care, is essential to malaria control in endemic areas, especially as increased uptake of the new preventive malaria vaccine lowers natural immunity, raising the need for widespread surveillance. The new test is highly sensitive, offers results in about 30 minutes, and can detect even a low density of parasites in the blood, catching malaria before a patient is sick.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. Last week, scientists announced a new project, funded by Wellcome, to expand the use of a low-cost, field-deployable, and real-time viral genome sequencing technique that has been widely used to detect COVID-19 variants to cover a wider variety of pathogens, helping public health officials surveil known and unknown pathogens of concern and respond to outbreaks more quickly and effectively. The project, which includes an international team of researchers, is supported by the Africa Centres for Disease Control and Prevention, the Asia Pathogen Genomics Initiative, and the World Health Organization International Pathogen Surveillance Network, which will help ensure that the system is broadly accessible around the world, even in places with limited resources and laboratory infrastructure.Harvard University researchers have found a drug combination that can kill the malaria parasite directly in mosquitoes so they can no longer spread the disease. Given the drugs can be absorbed the legs of mosquitoes, the goal is to create a cheap, long-lasting tool that could be applied alongside insecticides to bed nets in malaria-endemic regions. As resistance to the insecticides used on bed nets rises, this new method is less likely to lead to the emergence of resistance. The drugs, which were tested on materials similar to bed nets in a laboratory setting, killed 100 percent of the parasites. The method will be next tested in a real-world study in Ethiopia.A research team at Institut Pasteur has started a project testing a new rapid diagnostic that could detect the presence of the Plasmodium vivax malaria parasites early on after the initial mosquito bite—before symptoms arise—, helping patients receive appropriate treatment faster. Specifically, the researchers intend to design a test that can detect the presence of the parasite in blood samples from individuals whose infection is in the dormant liver stage, when it is difficult to detect infection. The project, which will run through 2030, has received around €6 million in funding from the European Union, as well as the British and Swiss governments.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. A new study found that LC16m8, an attenuated vaccinia virus strain originally developed in Japan for smallpox and later approved for mpox in 2022, induced strong responses and was safe in mice, monkeys, and healthy adult humans, potentially paving the way for the development of broadly effective mpox vaccines. The researchers vaccinated mice with LC16m8 to see how it protected them from mpox, later vaccinating monkeys and healthy adult volunteers as well to study their blood samples for immune responses and monitor them for safety. The results underscore LC16m8’s potential as a safe, effective, and scalable choice for mpox vaccination and also provide a blueprint for developing next-generation vaccines against other poxviruses and emerging pathogens.Researchers from Abertay University and Bangor University have developed a prototype blood test that can detect up to five infections at the point of care, providing results quickly via a smartphone app. The tool, which was piloted using tuberculosis as a test case, showed high sensitivity and an ability to accurately identify cases. The speed and convenience, as well as the much lower cost compared to lab testing, demonstrate the test’s potential to be a game changer in ensuring access to timely testing and diagnosis, particularly in remote locations and other settings lacking laboratory infrastructure.  The results of a Phase 3 clinical trial published last week found that Moderna’s combination COVID and flu shot outperformed existing individual vaccines for both viruses. The combination shot uses the same mRNA technology as Moderna’s approved vaccine for COVID-19, but there are no currently approved mRNA flu vaccines. In a trial that included more than 8,000 adults, the combination vaccines generated higher antibody levels for COVID and all but one influenza strain in trial participants who got the combination vaccine compared to those who got individual vaccines. A combination vaccine could help boost vaccination levels for both viruses, and an mRNA vaccine, in particular, could also speed up production because they are faster to make than current flu shots.