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. 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.

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, the US Department of Health and Human Services announced a $500 million investment into a vaccine project under a new initiative called Generation Gold Standard, which aims to advance universal influenza vaccines, hoping to get a vaccine into clinical trials next year and approved by 2029. The initiative, funding for which will come from the Biomedical Advanced Research and Development Authority, seems to be replacing Project NextGen, which had previously funded research into potential COVID-19 vaccines and treatments. Some experts and officials have expressed surprise at the direction of the initiative and the size of the investment.Scientists have discovered that a device used to diagnose bacterial meningitis in blood can also measure it in cerebrospinal fluid, helping speed accurate diagnosis and treatment of the illness, which is the most dangerous form of meningitis and a significant global health threat. The device has demonstrated high sensitivity in multiple cohorts of patients and it’s also affordable and delivers results within a half hour after spinal tap. The test was developed at an impressive speed, now available to patients within just a year of its discovery.Newly shared results from a clinical trial from the National Cancer Institute seem to confirm that a single dose of the vaccine used to prevent human papillomavirus (HPV) virus infection is just as effective as two, a finding that could transform efforts to reach the millions of children globally who are not getting vaccinated according to recommendations. Expanding HPV vaccination will also help reduce the global burden of cervical cancer deaths and deaths from other HPV cancers. While two doses are currently recommended, reducing the required dosage could make dissemination much easier and cheaper for many countries.

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 more than three million children, many from Southeast Asia and Africa, died in 2022 due to antibiotic-resistant infections, underscoring the urgent need for new and improved antibiotics to treat bacterial infections that are less likely to lead to the emergence of resistance, as well as new and improved antibiotics to address drug-resistant infections. Additionally, the study highlights the critical threat that antimicrobial resistance poses to children, in particular, who are highly vulnerable to infections, calling attention to the need for antibiotics that are safe and effective in this population.Researchers from Tulane University have developed a new smartphone-sized device that can deliver tuberculosis (TB) test results at the point of care in less than an hour, an innovation that could transform TB diagnosis, especially in low- and middle-income countries, where more than 90 percent of new TB cases occur. The low-cost, battery-powered device is the first that can detect the bacterium that causes TB in saliva in addition to blood and sputum, making it acceptable for use in children and people living with HIV, who may not be able to produce sputum. The technology was tested in children ages 1 to 16 in the Dominican Republic and demonstrated high sensitivity and specificity.A recent study found that a novel antibiotic compound is as effective at removing Methicillin-resistant Staphylococcus aureus (MRSA) as the current standard of care. The currently available antibiotics to treat skin infections caused by MRSA and other Staphylococcus strains can cause unpleasant side effects and are becoming less effective as these bacteria develop resistance to them. These promising results enable the researchers to continue preclinical development for the compound, specifically testing whether the compound can be incorporated into gels that can be applied to the skin to treat skin infections caused by MRSA and other bacteria, preventing the need for prolonged courses of current antibiotics.

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 led by a multi-country research team has found that the Xpert MTB/Ultra molecular diagnostic test for stool samples, which is currently only recommended for tuberculosis (TB) diagnosis in children, could serve as an alternative TB diagnosis option for adults living with HIV—a potential gamechanger for improving diagnosis among this population. Thirteen percent of the 1.25 million TB deaths in 2012 were among people living with HIV, but access to the sputum- and urine-based tests currently recommended for TB diagnosis in this population is limited in many settings, and they are not effective for all people living with HIV. The researchers found that, compared to current tests, the stool test was effective, and, in some cases, even identified additional cases that were not detected in sputum or bacterial culture.The Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) last week announced a $3.7 million award to ArrePath to support its first-in-class antibiotic for treating complicated urinary tract infections caused by multidrug-resistant Enterobacterales bacteria. If it proves successful, the novel antibiotic class could target the vast majority of multidrug-resistant Enterobacterales infections. The class of antibiotics also has attributes that suggest it could be administered orally or intravenously, allowing more flexibility for patients. ArrePath identified the new class using an artificial intelligence and machine-learning-enabled approach.Last week, the US Food and Drug Administration approved a freeze-dried formulation of Bavarian Nordic’s vaccine for mpox and smallpox, Jynneos, enabling additional flexibility in stockpiling doses of the vaccine to prepare for future outbreaks of smallpox or mpox. The freeze-dried vaccines are easier to store and transport and have a longer shelf life than the frozen liquid version, which was approved in 2019. Bavarian Nordic will deliver the first freeze-dried vaccines later this year.