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. As the dengue outbreak in Latin America has continued to grow and the threat of dengue continues to rise globally due to climate change, better and cheaper vaccines are on the horizon but are unlikely to be available soon enough to address the current crises. Currently approved vaccines for dengue include one expensive two-shot regimen and one that can only be given to people who have already been infected. A new, single-dose vaccine designed to target all four strains of the dengue virus, which was created by the US National Institutes of Health and licensed for development by the Brazilian Instituto Butantan, provided strong protection in a Phase 3 trial. The institute plans to submit the vaccine to Brazil’s regulatory agency for approval within the next few months, and if approved, the institute could start producing tens of million doses next year. Merck also licensed the vaccine technology and is developing a related vaccine for the rest of the world but has yet to test it in a clinical trial. In the meantime, the Brazilian government bought global supply of Takeda’s Qdenga vaccine, which, at a steep per-dose price, will provide some protection during the current outbreak. Takeda’s vaccine has also been licensed to an Indian generic drugmaker, but a slow start-up process means that is unlikely to be available before 2030.Pfizer recently announced that its RSV vaccine demonstrated the potential to protect adults between 18 and 50 at high risk of severe illness in a late-stage clinical trial, offering the promise of a tool to protect a far broader population against the virus that not only causes thousands of hospitalizations and deaths among older Americans and hundreds among infants every year but also can also cause severe illness in younger adults with weakened immune systems or underlying chronic conditions. Abrysvo is currently approved in the United States and elsewhere for adults 60 and older and expectant mothers. Pfizer announced plans to submit the final results from the trial for expanded approval of Abrysvo, although a timeline for submission has not yet been disclosed. Last fall, GSK released late-stage trial data demonstrating that its RSV vaccine could protect adults between 50 and 59 years old, and the US Food and Drug Administration is expected to make its decision on that vaccine in June.A research team from the Centre for Clinical Microbiology at University College London has developed a new method for testing tuberculosis (TB) that would allow lower-resourced laboratories in low- and middle-income countries (LMICs) to process samples safely, with the method primarily aimed at use for monitoring drug treatment response and clinical trials. The World Health Organization recommends monthly treatment monitoring with sputum culture to ensure patients are adhering to treatment to reduce the emergence of multidrug- or rifampicin-resistant TB, but monitoring with culture is often unavailable or incredibly slow in LMICs. The new method cuts out the need for a culture; uses common instrumentation available in most laboratories, even in LMICS; does not have high energy requirements; and takes only three or four hours to return a result. The method is already being used in clinical studies.

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. The first participants have been vaccinated in a Phase 2 clinical trial of a vaccine candidate for Lassa fever virus, which is being led by an international collaboration between IAVI, the Coalition for Epidemic Preparedness Innovations (CEPI), and in-country partners in Nigeria. Lassa fever is recognized by the World Health Organization (WHO) as a priority pathogen requiring accelerated research and causes an estimated 5,000 deaths each year, with the disease primarily affecting West Africa. There are no approved vaccines for Lassa currently. The hope is that this trial, which is the most advanced Lassa vaccine trial to date, will lead to the availability of a vaccine candidate for evaluation and use in future Lassa outbreaks and eventually an approved vaccine for routine immunization, as well as foster sustainable in-country research capacity and partnerships through engagement with Nigerian partners.Last week, FIND and LifeArc announced a new project in Kenya aimed at improving the detection and treatment of visceral leishmaniasis, a neglected tropical disease that mainly affects children and is fatal in more than 95 percent of cases if untreated. The project, which will run from 2024 to 2027, aims to increase early diagnosis and treatment to prevent disability and death from the disease in part by accelerating the development of new and improved diagnostic tests that are more sensitive than those currently available. The project will also build on ongoing efforts to improve community awareness, boost local and national testing capacity, and strengthen overall health system capacity.Last week, Cepheid announced that its point-of-care HIV test has received prequalification status from WHO. The decision will lead to the inclusion of the company’s HIV-1 PCR assay with extended coverage on a list of tests that meet WHO’s standards for global use, boosting access in low- and middle-income countries without designated or stringent regulatory authorities. The test can be used to detect HIV infection in infants and people who were recently infected and provides rapid results, enabling improved linkage to further care and treatment initiation.

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 Tuesday, Valneva announced the launch of a Phase 1 clinical trial to investigate the safety and immunogenicity of a vaccine against the Zika virus, for which there are currently no available preventable vaccines or treatments. The second-generation adjuvanted inactivated vaccine candidate, VLA1601, will be tested in 150 adult participants in the United States, with the first topline data from the trial expected as soon as early next year.  Numerous outbreaks of Zika have occurred around the world, but the virus is currently circulating in Mexico, Central and South America, the Caribbean region, and some areas of the continental United States.Moderna’s next-generation mRNA vaccine for COVID-19 elicited a higher immune response against most strains of omicron BA.4/BA.5 and the original virus than the company’s currently licensed vaccine and has a similar safety profile in Phase 3 trial. The vaccine candidate, mRNA-1283, demonstrated the highest benefits in patients over 65, who are at risk of more severe disease. The trial included over 11,000 patients from across the United States, the United Kingdom, and Canada. These results also point to the future promise of the company’s combination mRNA vaccines for COVID-19 and influenza, which are also currently in development and previously demonstrated a similar immune response to the company’s vaccines for COVID-19.The US Food and Drug Administration (FDA) recently announced the approval of Roche’s Cobas malaria test for screening blood, organ, and tissue donors, which could help reduce the risk of transfusion-transmitted malaria. The test is designed to qualitatively detect in whole-blood samples Plasmodium DNA and RNA from the five main species of Plasmodium parasite species known to cause human infection: P. falciparum, P. malariae, P. vivax, P. ovale, and P. knowlesi. Roche’s technology is now the first FDA-licensed test for screening blood donors for malaria.

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 Coalition for Epidemic Preparedness Innovations (CEPI) announced that it will give up to $14.9 million in funding for a new four-year project led by FIND to identify the most reliable tests to detect Lassa and Nipah virus infections, two zoonotic diseases that have, respectively, led to outbreaks in West Africa and South and Southeast Asia. The hope is the initiative will lead to the licensing and widespread availability of tests to help identify and contain future outbreaks early on, reducing cases and deaths of these serious diseases. This project will contribute to CEPI’s broader 100 Days Mission of rapidly developing tools against pandemic threats, as both diseases are among CEPI's priority pathogens.Researchers have developed a new synthetic antimicrobial compound, cresomycin, which can target many strains of antibiotic-resistant bacteria, including multidrug-resistant strains of Staphylococcus aureus and Escherichia coli. Many antibiotics work by binding to components of the bacteria that make proteins and disrupting them, but some bacteria have adapted resistance mechanisms to prevent this effect; cresomycin has improved binding ability. The researchers hope future studies will show that cresomycin and other compounds like it are safe for use in humans and effective against a variety of deadly resistant bacteria, paving the way for new solutions to stem the rising threat of antimicrobial resistance.A new study shows that Merck’s Ervebo Ebola vaccine was able to substantially lower the risk of people dying if they still developed the disease compared to those who were unvaccinated, even if they received the vaccine after they had already been infected. It is the first study to show that in addition to preventing infections, the vaccine can also save the lives of people who are already sick. The study, which looked at data from the 2018-2020 Ebola Zaire outbreak in the Democratic Republic of the Congo, found the fatality rate was halved among those vaccinated two or fewer days prior to illness compared to those who were unvaccinated. In addition to confirming the effectiveness of post-exposure use of Ervebo, the study also combated concerns that there might be interference between Ebola antibody treatments and the vaccine by showing that people who developed Ebola after being vaccinated were treated as effectively with antibody products as those who had not been vaccinated.