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 team of scientists at the Liverpool School of Tropical Medicine has discovered a new snakebite treatment that can prevent the devastating skin and muscle damage caused by African spitting cobra venom, which can lead to permanent injuries and disfigurements. There are currently no effective treatments for addressing severe bites caused by venom from the spitting cobra, which is responsible for a substantial portion of snakebites in Africa. The scientists found that repurposing the small molecule drug varespladib to target one of the two major toxins in the venom was effective, even when delivered up to an hour after the bite, and the drug also provided protection from venom-induced muscle toxicity.Newly shared research found that a dose-sparing mpox vaccine approach, which was used during the 2022 mpox outbreak in the United States as global vaccine supplies were stretched, is safe and effective. The study tested an intradermal mpox vaccination regimen in adults using the Jynneos vaccine containing either one-fifth or one-tenth the standard dose, finding the former was generated a comparable antibody response to the standard vaccine regimen. These findings underscore real-world data that have shown similar effectiveness for this dose-sparing intradermal regimen and the standard subcutaneous regimen. The new findings are also timely as a widespread mpox outbreak continues in the Democratic Republic of the Congo.Last week, Kephera Diagnostics announced that it received a two-year $606,498 grant from the US National Institutes of Health to help fund the development of a point-of-care test for congenitally transmitted (or mother-to-child transmitted) Chagas disease, which is believed to be the primary transmission method of the disease in the United States. The company will use the funding to develop a point-of-care blood test that can be used to diagnose infection at the point of delivery by measuring the levels of the antibodies that are believed to be the first to appear in the blood in response to infection and can be differentiated from maternal antibodies. Congenital Chagas can be treated with two drugs that are approved for pediatric use, but because the disease is often asymptomatic in newborns, it can resemble the symptoms of other infections and be hard to correctly diagnose.

Malaria is one of the world’s oldest and deadliest diseases. Thanks to international efforts to develop and scale up prevention tools and treatments, significant gains have been made over the past few decades in fighting this dangerous disease. But challenges, such as growing drug and insecticide resistance, climate change, and disruptions from COVID-19, have hampered control efforts. While both malaria cases and deaths steadily declined from 2000 to 2019, since then, cases have been on the rise and reported deaths have not returned to pre-pandemic levels—indicating progress against the disease has stalled and underscoring the need for continued research and development of new tools.In recognition of World Malaria Day, test your knowledge of this deadly disease and the innovations being advanced to end 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. The Combating Antibiotic Bacteria Biopharmaceutical Accelerator (CARB-X) last week announced that it will award up to $1 million to the company Scout to develop a rapid, inexpensive, and easy-to-use point-of-care diagnostic test for gonorrhea, which could expand access to testing and proper treatment in the face of a rise in gonorrhea cases and drug-resistant gonorrhea cases globally, especially in low- and middle-income countries. The test, STI-Scout, is designed to detect and differentiate between Neisseria gonorrhoeae and Chlamydia trachomitis and can provide results in only 30 minutes using urine samples or vaginal swabs at less than half the cost of other available tests. The test uses a proven isothermal technology that was validated for SARS-CoV-2 detection. Last week, EuBiologics and the International Vaccine Institute (IVI) announced that the World Health Organization (WHO) had prequalified Euvichol-S, an improved oral cholera vaccine produced with a simplified method that will hopefully help to address the rise of cholera outbreaks globally and a dire vaccine supply shortage. The vaccine, whose development was supported by the Bill & Melinda Gates Foundation, is produced in a way that can improve formulation and manufacturing productivity by 40 percent compared to the company’s prior oral cholera vaccine and demonstrated efficacy in a Phase 3 trial in Nepal last year. The prequalification paves the way for United Nations agencies and Gavi, the Vaccine Alliance, to buy the vaccine for countries experiencing outbreaks.The New Nets Project, funded by Unitaid and The Global Fund to Fight AIDS, Tuberculosis and Malaria, recently reported results from several pilot studies showing that a pair of second-generation bed nets tested in malaria-endemic areas helped to prevent up to 13 million additional cases of malaria, saving close to 25,000 lives—exciting news that comes as malaria cases, as well as resistance to the standard insecticide used to treat nets, rise globally. The studies found that the new nets, the Interceptor G2 and Royal Guard—which both use dual insecticides to address resistance—were between 20 and 50 percent more effective than traditional nets, which only use pyrethroid insecticide, in reducing mosquito exposure and reduced the risk of infection by up to 55 percent. Although the new nets are more expensive, the additional cost seems to be offset by the public health savings of malaria prevention. Researchers expect malaria parasites to eventually become resistant to the new nets, highlighting the need for continued research into other methods of vector control, as well as ensuring population-scale protection through vaccination.

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.