Breakthroughs Blog: Diagnostics

In 2023, tuberculosis (TB) retook the spot as the world’s leading infectious disease killer from COVID-19, claiming the lives of around 1.25 million people that year. Insufficient and inadequate tools and treatments and growing drug resistance have challenged global efforts to bring the TB epidemic to an end. In 2023, approximately 8.2 million people were newly diagnosed with TB, the highest number recorded since the World Health Organization (WHO) began global TB monitoring in 1995. At the same time, global funding for TB diagnostic, treatment, and prevention services fell in 2023 and globally, TB research remains greatly underfunded, with only 24 percent of the $5 billion annual target reached in 2023. Scientists hope that the tide can be turned as new technologies and innovations advance to market—but to achieve that, more investment is urgently needed to boost resources and reverse setbacks. In recognition of World TB Day, test your knowledge of innovations to end TB with GHTC’s quiz: 

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 Brazilian researchers has developed a simple test that can detect exposure to any of the four strains of dengue virus, as well as the Zika virus, as dengue cases continue to rise to a concerning degree in the region. The test was first validated with blood samples from mice experimentally infected with the viruses and then with hundreds of blood samples donated by people during the 2015-2017 Brazilian Zika epidemic. It uses technology that can be easily adapted for use in automated systems and rapid point-of-care tests and could serve as a key tool in the case of a Zika outbreak, allowing health care providers to test the immunity of at-risk groups while accounting for the possibility of cross-reactivity with antibodies produced after infection by dengue.Last week, IAVI and Biofabri announced that the first doses of tuberculosis (TB) vaccine candidate MTBVAC have been administered in a critical large-scale Phase 2b trial testing the safety and efficacy of MTBVAC to prevent active TB lung disease in adolescents and adults. While there is a vaccine for TB, it is more than 100 years old and has limited efficacy in preventing pulmonary TB, the most common form in adults. A new vaccine could be a game changer in the global fight against this leading infectious disease. MTBVAC is also a single-shot vaccine, making it easier to administer in low-resource and remote settings, and the partners developing it are committed to ensuring that, if proven successful in further trials, there will be a sufficient, affordable supply in the places where it is most needed.The Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) last week announced a $2 million award to Immunethep to develop a vaccine against invasive strains of Escherichia coli. The funding will support work on a conjugate peptide-based vaccine candidate designed to induce immunity to E coli, which can cause serious, life-threatening infections that are becoming harder to treat with the rising prevalence of antimicrobial resistance. There are currently no vaccines for E coli. The candidate has demonstrated efficacy against E coli, as well as four other priority bacterial pathogens in animal models, and, if it continues to prove successful, could be a key tool for preventing serious bacterial infections in vulnerable populations.

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, the World Health Organization (WHO) announced that it had prequalified a point-of-care assay that can help guide the treatment of Plasmodium vivax malaria. The assay, developed by SD Biosensor and PATH, detects glucose-6-phosphate dehydrogenase deficiency, which can lead to severe anemia in patients taking certain drugs to treat P. vivax malaria. This designation aims to improve access to the diagnostic in countries facing a high burden of malaria, enabling improved treatment for patients. The announcement arrives shortly after WHO prequalified two drugs for the treatment of P. vivax malaria last month.Researchers at the University of Minnesota and the Midwest Antiviral Drug Discovery Center have developed the first nanobody-based inhibitors targeting the Ebola virus, a deadly pathogen with a fatality rate of about 50 percent. Nanobodies are small antibodies derived from animals that can penetrate areas of viruses and human tissues that larger antibodies cannot reach, providing protection against infection. The team, which previously developed nanobodies to target COVID-19, found promising results for their nanobodies in lab tests in Ebola-infected mice. If this research continues to be successful, it could pave the way for treatments not only for Ebola but also for other viruses in the same family, including Sudan ebolavirus and Marburg virus.Last week, the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) announced $2.6 million in funding to Clarametyx Biosciences to develop an anti-biofilm vaccine that could help prevent serious bacterial infections and mitigate the rise of antibiotic resistance. Specifically, the funding will support the further development of the company’s pathogen-agnostic vaccine candidate designed to prevent the formulation of bacterial biofilms, which are protective layers that bacteria use to shield themselves from antibiotics and the immune system, therefore allowing the body’s immune system to clear infections without the use of antibiotics. Hard-to-treat bacterial infections associated with biofilms are estimated to be responsible for up to 80 percent of bacterial infections and are known to contribute to the emergence of antibiotic resistance.

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, Detect Diagnostics announced that it received approximately $5.9 million in grants from the Bill & Melinda Gates Foundation to support further development of the company’s infrared light-based point-of-care system and assays to detect protein biomarkers of infectious disease. The Visualization by Infrared PEptide Reaction (or VIPER) diagnostic technology can detect bacteria, viruses, and fungi directly from samples and is simple to use, fast, low-cost, sensitive, and portable, making it suitable for low- and middle-income countries, which face a high burden of infectious disease. The grants include specific funding to advance the development of a test to detect tuberculosis.Last week, the National Institute of Allergy and Infectious Diseases and Siga Technologies announced that patients are no longer being enrolled in a clinical trial testing the antiviral drug tecovirimat (or Tpoxx) as a treatment for mpox. The study’s Data Safety and Monitoring Board recommended cessation after the drug did not hasten lesion healing or pain relief in adults with mild to moderate clade 2 mpox at low risk for severe illness, and an additional assessment showed a less than 1 percent chance that the study would demonstrate efficacy if enrollment and follow-up were completed. This news comes amid the ongoing global outbreak of clade 1 mpox and following the 2022 global outbreak of clade 2 mpox. While this trial and another testing Tpoxx for mpox did not show that the drug helped to accelerate lesion healing, before 2022, no treatment candidate had been studied in people with mpox, and this research represents an important step in the ongoing work of finding tools to address mpox.A recently published study introduces a proof-of-concept for a novel class of antivirals targeting a type of enzyme essential to several families of viruses—which include several pathogens that scientists believe are most likely to cause the next pandemic—, potentially paving the way for a faster and more robust response to future outbreaks. The research team screened hundreds of thousands of compounds, using the ones they discovered to create an optimized drug candidate that was then tested in mice, finding that the candidate could treat COVID-19 on par with Paxlovid, remain effective even if the virus mutated, and cause minimal side effects. The researchers say they need an industry partner before they can test the compound in humans, but they are working on developing compounds that could target other priority viruses that share the targeted enzyme, including RNA viruses like Ebola and dengue, as well as cytosolic-replicating DNA viruses like mpox.