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 an at-home, over-the-counter assay for hepatitis C virus (HCV), the first self-test to be prequalified for HCV, which causes an estimated 1 million new infections globally each year. The prequalification of the assay, manufactured by OraSure Technologies, extends the 2017 prequalification of the company’s HCV test for professional use. Self-testing is recommended to complement existing testing services based on evidence demonstrating that it increases access to and uptake of services. The prequalification status will hopefully enable procurement in low- and middle-income countries, expanding access to HCV testing and treatment services and helping to contribute to the global goal of HCV elimination.The Safety of Antimalarials in First Trimester consortium, made up of scientific and social research experts on malaria in pregnancy has kicked off preparation for the first-ever Phase 3b clinical trial testing the efficacy and safety of antimalarials in women in their first trimester of pregnancy, which will be cosponsored by Medicines for Malaria Venture and the Liverpool School of Tropical Medicine. Pregnant women are typically excluded from clinical trials out of fear of causing harm, leaving few medicines for malaria treatment and no medicines for prevention available for women in their first trimester despite the significant health risks associated with malaria in pregnancy. The data from this trial could enable pregnant women and all women of childbearing age to safely take these antimalarial medicines without risk of causing harm, as well as support the design of future trials targeting other infectious diseases affecting pregnant women in low- and middle-income countries.  New research has led to the discovery of a potent adjuvant, PVP-037, that could induce a greater, more durable, and broader immune response to vaccines. Adjuvants are compounds that enhance the immune response, which are key to vaccine development, particularly for inactivated virus vaccines. Researchers identified the compound by screening a library of more than 200,000 small molecules found in human immune cells. In mice, an optimized form of the adjuvant boosted antibodies against flu and SARS-CoV-2 when given alongside disease-causing antigens. The compound is stable, easy to work with, and can be formulated in most drug delivery systems, which would make it easier to integrate it into vaccine development. Further research will be needed to study how the adjuvant performs in the presence of actual pathogens, assess its impact on the durability of immune responses, and test whether it works across age groups.

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 US Department of Health and Human Services, through the Biomedical Advanced Research and Development Authority, has awarded $176 million to Moderna to support the continued development of a pandemic influenza vaccine that could be used to treat bird flu in people, as concerns about the spread of bird flu cases in dairy cows across the United States continue to rise. Moderna's bird flu vaccine candidate is in very early-stage testing and uses the same mRNA technology as its COVID-19 vaccine. The new funding could support a late-stage trial of the vaccine candidate as early as next year if early study results continue to be positive. The vaccine could also be quickly redirected to target another form of influenza if a different threat emerges.A research team has developed a test that will help measure the persistence of HIV in people affected by viral strains found predominantly in Africa, which are greatly understudied, helping to fill a major gap in HIV research. Most HIV studies have focused on the strains circulating in Western countries, predominantly by men who have sex with men affected by subtype B, with much fewer studies examining strains circulating in Africa, where women are disproportionately affected. The new laboratory test allows researchers to determine whether following antiretroviral treatment there is any intact viral DNA capable of producing new viruses if antiretroviral treatment is interrupted. The test is already being used to study long-term viral persistence in Uganda and could be a vital tool in the search for an HIV cure that could target and eliminate this intact DNA reservoir.Last week, the US National Institutes of Health (NIH) announced the launch of a Phase 1 trial testing a nasal vaccine against COVID-19, the first trial conducted by NIH’s National Institute for Allergy and Infectious Diseases as part of Project NextGen, a US government initiative designed to advance the development of next-generation COVID-19 vaccines. In preclinical nonhuman primate studies, the candidate, MPV/S-2P, elicited a strong systemic immune response, as well as mucosal immunity, which plays an important role in controlling respiratory virus replication. Next-generation vaccines, including nasal vaccines, are a key tool needed to reduce COVID-19 infections and transmission as new variants of the virus continue to emerge.

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 Thursday, Roche announced that its molecular Cobas HPV test received prequalification designations from the World Health Organization (WHO), a decision that will hopefully boost global efforts to eliminate cervical cancer through improved access to testing. The test received prequalification designations for use on the Cobas 5800 system and for self-collected samples on the Cobas 5800, 6800, and 8800 instruments, already having received WHO prequalification for use on the Cobas 6800 and 8800 systems last year. Prequalification will expand the availability of the test in many low- and middle-income countries that rely on prequalification to make regulatory, purchasing, and implementation decisions. Additionally, the use of self-collection, which was also recently approved by the US Food and Drug Administration, is expected to increase access to HPV testing by increasing comfort and ease for users.  The Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) recently announced a $1 million award to Prompt Diagnostics to further the development of a portable, point-of-care platform to detect multiple pathogenic bacteria targets and their antibiotic susceptibility, an urgently needed technology to help address rising drug resistance globally. Rapid, sophisticated diagnostics can enable early detection of infections, more effective treatment management, and improved antimicrobial stewardship to help prevent the emergence and spread of drug resistance, particularly in low-resource settings where drug-resistant infections are particularly hard to treat and the burden of drug resistance is highest. Specifically, CARB-X hopes the platform will demonstrate feasibility for detecting gonorrhea infections in the face of disproportionately high rates of gonorrhea in low- and middle-income countries.New research shows that a novel genetic vector control technique is highly effective at reducing the population of Anopheles gambiae, the primary vector for malaria in Africa. The technology could eventually serve a crucial role in reducing malaria transmission, especially as conventional methods, including insecticide-based technologies and environmental controls, are becoming less effective due to insecticide resistance. The precision-guided sterile insect technique uses CRISPR, a gene-editing tool, to produce genetically modified highly sterile male mosquitoes that then mate with and sterilize female mosquitoes, leading to robust population suppression. Developers say that compared to other genetic modification technologies developed for this mosquito species, the new technique is safer, scalable, and confinable.

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 Global Health Innovative Technology (GHIT) Fund awarded a two-year grant to the Drugs for Neglected Diseases initiative (DNDi) and its partner Mitsubishi Tanabe Pharma Corporation to continue lead optimization work on a novel compound to target the Trypanosoma cruzi parasite that causes Chagas disease, a neglected parasitic disease that affects an estimated 6 million people globally every year. Current treatments for Chagas, which were developed decades ago, need to be administered for eight weeks, can have serious and potentially toxic side effects, and have not been proven effective in people with severe chronic symptoms. The partners hope their work will lead to preclinical development candidate compounds and, eventually, a new medicine for Chagas disease that is safe and effective for all patients, including pregnant individuals.Researchers have developed an experimental vaccine that has the potential to protect against a broad range of coronaviruses, including known and as-of-yet-unknown varieties. The experimental vaccine was made by taking harmless proteins shared across different coronaviruses and attaching them to minuscule nanoparticles that are then injected to prime the body’s immune system to broadly target both known and unknown viruses in the same family. The vaccine induced a broad immune response to coronaviruses in mice, including to the pathogen that caused the 2003 Sars outbreak, even though proteins from that virus were not added to the vaccine. If proven safe and effective in humans, this and other proactive vaccines designed to target separate pathogens could be stockpiled by countries along with clear plans to quickly scale up production if a new pandemic-potential pathogen emerges. The universal vaccine can be made in existing facilities for microbial fermentation, and the researchers are already working with industrial partners on how to scale up production. There would need to be new processes designed with medical regulators before approval because there are no current procedures for the regulation of proactive vaccinology.Last Monday, the Biomedical Advanced Research and Development Authority announced the launch of the next generation of its accelerator network, which will include a diagnostics and medical devices program and a therapeutics hub. The former will be called the International Consortium for Research, Engineering, Acceleration of Technology Excellence and will support the development and acceleration of new diagnostics and medical devices aimed at improving health security. Along with three more hubs expected to be announced later this year, these hubs will create a global network to foster the growth of the health security innovation ecosystem, including support across the entire process, from development and evaluation to validation and commercialization of new technologies.