Breakthroughs Blog: Diagnostics

Universal health coverage (UHC)—the idea that everyone, everywhere, should be able to access quality health services—will take center stage at the World Health Assembly (WHA) later this month. World Health Organization (WHO) Director-General Dr. Tedros Adhanom Ghebreyesus has made UHC a top priority, as his institution estimates that at least half of the world’s population still does not have full coverage of essential health services.While there are many building blocks to achieve UHC—from galvanizing political will and investment to strengthening health systems and training health personnel—one integral pillar that is too often overlooked is innovation—the creation of new and improved drugs, vaccines, and diagnostic tools. Global health research and development (R&D) is indispensable in delivering on the vision of quality health for all. R&D a vital component to achieve UHCHealth systems cannot meet the fundamental needs of their populations without high-quality and accessible drugs, vaccines, and diagnostics with which to treat, prevent, and detect disease. Today, we still lack many of the tools needed to combat diseases and conditions that exact a tremendous health burden in the world’s poorest places. No preventative vaccines exist for many neglected diseases, including Chagas, leishmaniasis, and chikungunya, and treatments available are often inadequate or toxic. Tuberculosis (TB) sufferers today face six to twenty months of treatment, involving thousands of pills and painful injections. We still don’t have the right tests to diagnose many infectious diseases at point of care, leaving patients wondering and waiting for care. The goal of ending AIDS will remain out of reach without a vaccine or cure. Meanwhile, growing antimicrobial resistance (AMR) against malaria, TB, and other infectious diseases threatens to roll back progress and is adding even greater urgency to the need to develop new innovations to prevent emerging resistance. Neglected diseases affect hundreds of millions of people worldwide and jeopardize achieving UHC for the most vulnerable among us.As the global community invests in policies and programs that support UHC, it must also prioritize R&D for new health technologies, especially where markets don’t catalyze these investments on their own. It will be impossible to truly deliver quality care for all without new innovations. Delivering the next generation of lifesaving health technologies will require strong political commitment and increased investment from all nations. To make that happen, it’s critical that the world explicitly acknowledge the importance of global health R&D to attaining UHC.WHO’s role WHO has a crucial role to play in strengthening R&D and access to achieve UHC. Through its global convening power, WHO sets the agenda and is often the institution policymakers rely upon to frame their countries’ health priorities and lead the implementation of important programs vital to improving access to quality treatment and services. For example, WHO’s essential medicines and diagnostic lists are highly vetted, evidence-based recommendations that provide member states with a robust framework to determine key investment, health service, and policy priorities. WHO also provides technical expertise and capacity-building programs to build regulatory frameworks that accelerate access to medicines and create stronger enabling environments for global health R&D. This includes supporting the development of laboratory systems and infrastructure, as well as clinical trial capacity. For everything ranging from establishing safety standards, to producing treatment guidelines for infectious diseases, to designating good clinical research practices, WHO sets the normative technical standards and provides clear targets for low- and middle-income countries for health system strengthening. WHO must continue to use its global convening power to facilitate coordination and alignment of priorities in order to advance the UHC agenda. This is why the 72nd WHA meeting presents the global health community with an opportunity to ensure that WHO continues to play a significant role in supporting R&D by stepping up its efforts to catalyze additional investment, build capacity, and provide resources to stakeholders to facilitate the development and effective deployment of tools to patients globally. While governments can, and should, play a leading role in the global UHC movement, WHO will also play an important part in making the vision of quality health for all a reality. As the world gets ready to descend on Geneva for WHA week, global health advocates should remember that there is no UHC without R&D.

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 landmark study found that men whose HIV infection was fully suppressed by antiretroviral drugs had no chance of infecting their partner—suggesting that if everyone with HIV were fully treated, there would be no further infections. Of the nearly 1,000 male couples across Europe who participated in the study, in which one partner with HIV was receiving treatment to suppress the virus, there were no cases of transmission of the infection to the HIV-negative partner during sex without a condom. According to Professor Alison Rodger, co-leader of the paper published in The Lancet, these findings “provide conclusive evidence for gay men that the risk of HIV transmission with suppressive ART [antiretroviral therapy] is zero” and that the study’s findings “support the message of the international U=U campaign that an undetectable viral load makes HIV untransmittable.” The Global Polio Eradication Initiative (GPEI) unveiled a new five-year strategy on Tuesday, which includes the use of novel oral polio vaccines—several of which are being developed by PATH and its partners—as well as the adoption of smartphone technologies to assist in disease surveillance and faster response. GPEI is also planning to establish a regional hub in Amman, Jordan to allow for easier coordination and increased technical support for polio vaccination programs in Afghanistan and Pakistan, two polio-endemic countries. Additionally, as part of the new strategy, GPEI is expanding its partnership with development institutions such as Gavi, the Vaccine Alliance. These new approaches, among others, will be implemented by GPEI under its new strategy from 2019-2023 in the hopes that this new strategy will be its last, with wild poliovirus successfully eliminated by 2023. The new strategy is currently facing a funding gap of US$3.27 billion, which organizers hope to fill with a pledging conference in November. On Wednesday, the US Food and Drug Administration (FDA) approved the first vaccine against dengue fever. The vaccine, Dengvaxia, has generated much controversy in recent months due to post-marketing research performed by its manufacturer, Sanofi Pasteur, which showed that the vaccine offers protection for people who have already had at least one bout of dengue, but increases the risk of severe infection in children who were dengue-naïve, or never infected when they were vaccinated. The FDA ruled that Dengvaxia can only be administered to individuals between the ages of 9-16 living in parts of the United States where the dengue virus is endemic, and that it can only be given to children and young adults who had one previous laboratory-confirmed case of dengue. Identifying these individuals with prior infection is currently a challenge, because there is no point-of-care diagnostic test available, though Sanofi officials say they have to have one ready for FDA submission by late 2020. Sanofi will earn a priority review voucher (PRV) by bringing Dengvaxia to market. A PRV is an incentive created to encourage pharmaceutical companies to develop drugs and vaccines for neglected diseases and, in exchange, allows a company to expedite the review of another product it wants to bring to market or sell the voucher to another company.

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. In pursuit of a malaria vaccine, the biotech firm, Sanaria, has partnered with roboticists at Johns Hopkins University to develop a guillotine to decapitate and dissect out the salivary glands of mosquitoes, which hold the malaria-causing parasite. This guillotine, which can decapitate 30 mosquitoes at a time with the guidance of a “mosquito surgeon,” will help Sanaria effectively mass-produce its malaria vaccine candidate, PfSPZ, which requires one whole malaria parasite per vaccine dose. Eventually automating this process, even partially, would likely boost the mosquito dissection rate above the current average of 300 mosquitoes per hour achieved by highly trained technicians. The PfSPZ vaccine, which is currently in phase 2 clinical trials, is thought to work by inducing killer T cells to attack the parasites in the human body as they’re developing in the liver. Scientists at Oxford University have harvested antibodies from volunteers vaccinated in research trials of an Ebola vaccine to develop a treatment for the viral infection. Traditionally, antibodies intended for treatment are collected from the blood of people who have survived infection. This technique instead uses antibodies collected from those who have been exposed to the Ebola vaccine but not the Ebola virus itself—suggesting that protective therapies can be developed from people who are disease-free. To create the experimental treatment, scientists made a cocktail of four antibodies from trial volunteers who had been given an experimental Ebola vaccine and whose immune system responded to the shot by making antibodies. This cocktail successfully cured six guinea pigs of the virus when administered three days after infection. The research team believes this approach could be used for other emerging diseases caused by viruses. Brazilian researchers say they have developed a simpler, cheaper, and faster method to diagnose the Zika virus that doesn’t require laboratory equipment or trained staff. The method uses a technology called loop-mediated isothermal amplification (RT-Lamp), which amplifies the viral genome of the biological sample to detect the virus. While the current method of detecting Zika virus, polymerase chain reaction (PCR), is considered the gold standard for virus detection, it requires expensive equipment, specialist staff, and laboratories with good infrastructure. On the other hand, RT-Lamp has the ability to detect a very low quantity of the virus and has an individual cost of around US$0.25 compared to $10 for the PCR test. The RT-Lamp technology has long been used for other diseases, such as Ebola, but not for Zika. The authors of the study have requested a patent of this technique and hope to transform the technology into a commercial kit to be used for diagnosing patients.

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 government of the United Kingdom (UK), through a public-private partnership called UK Research and Innovation, is building the country’s first vaccine manufacturing and innovation center with additional funding and expertise from Janssen, Merck & Co., and Wellcome Trust. The center will focus on creating rapid, cost-effective ways to develop and manufacture vaccines for clinical trials and global distribution, with Ebola and Lassa fever among the infectious diseases the center will tackle. The vaccine manufacturing and innovation center will be based in Oxford and is slated to open in 2022. A comprehensive study in The Lancet Infectious Diseases shows the remarkable genetic diversity of HIV and reveals how the subtypes of the virus are distributed by country and region and where new strains are emerging. The systematic review and global survey found that the greatest diversity of HIV exists in Central Africa and subtype C causes the greatest number of HIV infections globally. Subtype C was also found to be the near-exclusive strain of HIV in southern Africa, where HIV prevalence is highest, strengthening the case for prioritizing the development of an HIV vaccine specific to this subtype. Overall, the study also highlighted the challenging nature of developing a vaccine against a virus that is so genetically diverse and widespread. Researchers from Loyola University Chicago Stritch School of Medicine have developed six antibodies that could be used to test for and potentially treat Zika—a virus which has afflicted more than 1.5 million people worldwide and for which there is no effective vaccine or treatment. Inexpensive to produce and identifiable via means like a simple filter paper test in the field, these antibodies have the potential to provide protection against the virus or could also be used in an antibody-based diagnostic test for Zika, potentially providing an inexpensive and quick means of monitoring for the virus. One researcher noted, “Rapid spread of the disease within the epidemic regions, coupled with migration of infected persons, has underscored the need for rapid, robust and inexpensive diagnostic tools and therapeutics.”