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. 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.

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 research team was able to induce broadly neutralizing antibodies targeting hepatitis C virus (HCV) in laboratory models for the first time, providing a promising approach for a vaccine targeting the virus, which an estimated 58 million people globally are chronically infected with and which causes 290,000 deaths annually. HCV is identified as a globally prioritized pathogen for vaccine research and development by the World Health Organization, but developing a vaccine has been a challenge due to the high genetic diversity of the virus. This new approach, if proven successful in further studies, could not only bring us closer to an effective HCV vaccine that could help limit the spread of the virus but could also lay the foundation for a new generation of vaccines against other priority viruses.Last week, the World Health Organization (WHO) announced that it had granted prequalification to Cepheid’s Xpert MTB/RIF Ultra rapid diagnostic test for tuberculosis (TB), the first TB diagnostic test to be prequalified by WHO. The designation will hopefully help ensure broader access to the product, allowing for accurate and early detection of TB, especially drug-resistant TB. Within hours, the test detects the genetic material of Mycobacterium tuberculosis in sputum samples and identifies mutations associated with rifampicin resistance, a key indicator of multidrug-resistant TB. A recent report found that 8.2 million people—the highest number of cases recorded by WHO since it began global TB monitoring—were diagnosed with TB in 2023, underscoring the need for greater access to new and improved tools.Last week, the World Health Organization (WHO) announced that it had granted prequalification to tafenoquine, the first single-dose medicine for the prevention of Plasmodium vivax malaria, and also included tafenoquine, co-administered with chloroquine, in the new WHO malaria guidelines for South America. P. vivax is the dominant malaria parasite in most countries outside of sub-Saharan Africa, with children under five and migrant populations at particular risk. The prequalification and inclusion of tafenoquine in the updated guidelines are aimed at improving access to the treatment, which is shorter and simpler than current treatment regimens.

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 New England Journal of Medicine published the full results of the PURPOSE 2 trial testing Gilead Science’s twice-yearly lenacapavir shot for HIV prevention, finding that it was extremely effective in a broad and geographically diverse range of cisgender men and gender-diverse people. These results follow those of the first PURPOSE trial published earlier this year, which found that the drug was 100 percent effective as a prevention option in a study of women and adolescent girls. Lenacapavir is already approved and available in several countries, including the United States, as an HIV treatment option. With additional approvals as an HIV prevention option, the shot could be a game-changer for many marginalized communities that face the highest risk of HIV infection.A recent study found that the investigational drug quabodepistat in combination with delamanid and bedaquiline demonstrated safety and efficacy as a treatment for pulmonary tuberculosis (TB). TB treatment has historically been months long and difficult to tolerate, leading to discontinued treatment courses that raise the risk of the emergence of drug resistance. This combination treatment could potentially help fill the gap for safer, shorter regimens that cause fewer side effects. Further large-scale and long-term trials will be needed to validate these findings before this treatment combination can be available to the communities that face the highest burden of TB.Last week, the US Department of Health and Human Services announced nearly $27 million to support the rapid development and scale-up of manufacturing capacity for diagnostic tests to address future biologic threats through the Biomedical Advanced Research and Development Authority consortium. The COVID-19 pandemic exposed the gap in the United States' capacity to quickly develop, validate, produce, and roll out diagnostic tests to curb the spread of an infectious disease outbreak. While the funding will specifically support the development of tests to detect Burkholderia pseudomallei, the bacterium that causes melioidosis, and Marburg virus, the aim is to advance diagnostics platforms that can be leveraged to quickly produce tests for other threats as they emerge.