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. After hitting its primary goal in a phase 2 trial, Themis may be one step closer to developing a vaccine to protect against chikungunya—a disease which causes debilitating joint pain and for which there is currently no treatments or vaccines. MV-CHIK, Themis’ chikungunya vaccine candidate, was tested at two dose levels in a total of 263 participants and was found to induce neutralizing antibodies against the disease in all groups after two injections. Themis reported seroconversion rates ranging from 86 to 100 percent, touting the vaccine candidate as “promising and potentially effective” against the disease. Themis is looking to move the vaccine candidate into a phase 3 study “in the near term” and will likely pursue a priority review voucher, as the US Food and Drug Administration recently added chikungunya to its list of eligible diseases.  A new study suggests that frontline health workers in the Democratic Republic of Congo who received experimental Ebola vaccines could be protected against the virus for longer than a year. The study, which tracked healthy volunteers in the United Kingdom who received vaccines against Ebola between 2014-2016—including Merck’s rVSV-ZEBOV, GlaxoSmithKline’s ChAd3 EBOV, and Janssen’s AdHu26—found that after two-and-a-half years, those vaccinated still have a strong antibody response to the virus. These findings provide insight into how the vaccines can be used in future outbreaks in the region and how health care workers could be vaccinated before the disease becomes widespread during an outbreak. Researchers now plan to give a booster dose to the study participants to determine how it adds to their immunity. By utilizing the same technology used to develop the Ebola vaccine—a technology known as viral vectors—researchers also believe they can speed the development of vaccines for other infectious diseases. Researchers at the University of Southern California believe they have identified a panel of biomarkers specifically associated with symptomatic Zika infection during pregnancy—a discovery which could lead to the development of new prenatal screening tests to detect fetal abnormalities caused by the virus, as well as a better understanding of how Zika causes these abnormalities. During the study, researchers examined the immune systems of pregnant women through blood samples—comparing the samples of 30 Zika-infected pregnant women in Brazil to 30 healthy pregnant women in Brazil and 14 in Los Angeles. The researchers specifically examined cytokines, messenger chemicals released by the body in response to an infection, and identified 16 cytokines associated with abnormal births from Zika. However, it is unclear if the cytokines cause the birth abnormalities or are released in response to another cause.

One of the great things about working at GHTC is that every day we get to read stories about incredible innovations in global health. Most of the technologies we read about are inventive, some are revolutionary, and a few are so unusual, one might think they were ripped from the pages of a science fiction novel. So, to enjoy a bit of fun and mischief this Halloween, we’ve created a new game, TRICK or TREATment, to test our readers’ knowledge of global health technologies. For each question, we will present a description of a global health technology. Choose TREATment if you believe this innovation exists and has market approval. Choose TRICK if you think we are trying to pull one over on you and, instead, the product is still in development or just a figment of our imagination.  Loading... (function(i, s, o, g, r, a, m) { var ql = document.querySelectorAll('A[quiz],DIV[quiz],A[data-quiz],DIV[data-quiz]'); if (ql) { if (ql.length) { for (var k = 0; k

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 a new report, researchers at the Johns Hopkins Center for Health Security highlight 15 promising technologies that could help make the world better equipped to fight emerging infectious disease (EID) outbreaks and prevent such outbreaks from becoming catastrophic events. The list includes innovative solutions from vaccines that spread through populations like viruses to 3D printed drugs. The 15 technologies identified in the report fall under five broad categories—disease detection and surveillance, diagnostics, manufacture of pharmaceuticals, administration of vaccines and drugs, and medical care—and range in use from the early detection of an EID, to preventing its spread, and through to the care of patients. Notably, researchers looked for innovations that could be used in developing countries where EID outbreaks “hit first and hit hardest,” according to Dr. Crystal Watson, lead author of the report.  A novel synthetic DNA vaccine candidate against Ebola, which targets the virus’ surface, offered complete protection from the Zaire strain of the Ebola virus in preclinical research. Importantly, the vaccine candidate also demonstrated durability, showing strong immune responses one year after the last dose—a particularly challenging area for Ebola vaccines. Compared to traditional vaccine approaches that involve injection into muscle, synthetic non-viral–based DNA vaccines can be administered directly into the skin, resulting in consistent, potent, and rapid immunity. The antibody levels resulting from this vaccine candidate were equal to or higher than those for other vaccines currently being evaluated in the clinic at the Wistar Institute Vaccine & Immunotherapy Center, where the research was conducted. One researcher noted the success of an intradermal, low-dose regimen as encouraging in the pursuit to create safe and effective vaccines that are optimized for high-risk areas. A new type of malaria vaccine, known as a transmission-blocking vaccine (TBV), which aims to prevent mosquitoes from becoming infected by malaria parasites when feeding on infected humans, could one day become part of a suite of tools used to combat malaria. While traditionally scientists have focused on developing vaccines that prevent malaria infection from developing after a person is bitten with a parasite-carrying mosquito, a TBV works differently. A TBV signals the human body to begin making anti-malaria antibodies that will be passed to the mosquito when it bites the immunized person, disrupting the transmission cycle between mosquitoes and humans. While a TBV would not directly prevent an immunized person from getting infected, it would reduce the likelihood of people in that community becoming infected. A research team supported by the PATH Malaria Vaccine Initiative, the University of Buffalo and others have shown that the TBV approach could be effective. The researchers found that antibodies from a protein called Pfs25 effectively blocked the development of malaria-causing parasites in the gut of mosquitoes in animal studies.

A “who’s who” of politicians, philanthropists, CEOs, and civil society leaders descended upon New York City this week for the annual United Nations General Assembly (UNGA)—a gathering renowned for its policymaking, pledging, and perennial traffic problems. GHTC was on the scene all week—attending side events, tuning into the official debates, and navigating police barriers—to be your eyes and ears on the ground. Here is what we heard and our top four takeaways on global health research and development (R&D): 1. We can’t end TB without new tools, so it’s vital for world leaders to marshal the political will and resources to close the TB R&D funding gap. Tuberculosis (TB) was a top topic at this year’s assembly with the convening of the first high-level meeting (HLM) on TB. Repeatedly, we heard—from advocates and policymakers, at side events and in in the official proceedings—how poor treatment options are a cornerstone of our failure to eradicate TB and of growing drug resistance, and that new vaccines and improved treatments and diagnostics will be key to turning the tide. While much attention focused on this lack of necessary tools, equal attention focused on the lack of political will and resources to end the epidemic. Many speakers lamented how shamefully slow progress has been since the World Health Organization (WHO) declared TB a global emergency 25 years ago and highlighted the urgent need to close the funding gap for TB, including the US $1.3 billion gap for TB R&D.   As the curtain closed on the HLM, world leaders, as expected, endorsed a carefully negotiated political declaration. GHTC was pleased to see it include a commitment to increasing investment in TB R&D by $2 billion and strong recognition of the importance of cross-border, cross-sector collaboration in driving product development. However, we also share concerns raised by other advocates on accountability. For this meeting to catalyze true change, rhetoric must now translate to action, and commitments must be matched with mechanisms that track investments and hold nations accountable. 2. There are many roads on the path to universal health coverage, but innovation can be an accelerator. Universal health coverage (UHC) was another topic that took the spotlight at UNGA 73, championed by the issue’s top “cheerleader in chief” WHO Director-General Dr. Tedros Adhanon Ghebreyus, who has made achieving UHC a centerpiece of his directorship. Given the focus of the world’s doctor on UHC, many advocates at UNGA framed their specific issues through the lens of UHC, highlighting the myriad of steps needed to achieve this ambitious goal‒from building a stronger health workforce, to expanding access to medicines, to tackling leading killers like malaria, HIV and AIDS, and TB. Yet, a common theme heard across these conversations is that along each of these roads, innovation can be an accelerator.   Throughout the week, speakers highlighted how innovations and new technologies can help deliver care more efficiently and effectively, improve access and drive down costs, and accelerate countries along the path to achieving UHC. TB advocates highlighted how shorter treatment regimens can improve care, decrease costs, and free up resources, while digital health advocates argued that better use of data can empower health workers to track and treat patients and allocate precious health resources most effectively. Others highlighted how innovative new tools like point-of-care diagnostics can bring improved care to the community level and to people in the most remote corners of the globe. 3. We need additional resources for R&D, and that requires countries to step up in an equitable way. Domestic resource mobilization and equitable financing were words repeated throughout the week, particularly in conversations around the TB HLM and closing the TB R&D funding gap. Advocates, think tanks, and even government officials, argued that high-burden TB countries need to increase domestic investment in TB R&D and treatment. Some advocates have called for a “fair share” or equitable financing approach to TB R&D financing, with each country committing to spend .1 percent of their GDP on R&D. Others spoke to the potential of the BRICS nations—Brazil, Russia, India, China, and South Africa—to play a greater role in financing R&D.   While much of the TB financing dialogue focused on increasing public sector contributions, conversations also highlighted the impact and further potential of financing models like the airline-tax-funded work of UNITAID or public-private partnership approaches—like product development partnerships and the work of the Global Health Innovative Technology Fund—which have married multisector contributions to bring novel, affordable, accessible tools to market. Other speakers highlighted the opportunity for industry to increase its TB R&D investment, though many lamented that although industry has brought new TB drugs and diagnostics to market in recent years, uptake has been slow due to high product costs. 4. There is reason for optimism and reason for concern. The mood seemed mercurial in midtown Manhattan, as UNGA orators vacillated between optimism and concern about the future of global health and development. In the drumbeat to UNGA, the always-impatient optimists Bill and Melinda Gates unveiled their foundation’s Goalkeepers report. The report’s stylish line graphs, which show a downward trajectory on health issues like child mortality, are uplifting and inspiring—a great reminder of the staggering progress we’ve achieved in global health and what’s possible for the future.   The basis of our optimism about the world has always been our belief in the power of innovation to redefine what’s possible – Bill and Melinda Gates   Yet, three years in, it has also become clear the world is not on track to meet the Global Goals. And even the optimistic Gates are reminding us that though we hold the blueprint for a healthier world, continued progress is not inevitable. The choices our policymakers implement today will determine whether progress continues or stalls. Throughout the week, many speakers gave voice to fears, highlighting concerns that foreign aid spending is under increased attack in leading donors countries like the United States—a notion echoed in President Trump’s speech to the Assembly—and that political changes like Brexit and an “America First” doctrine signal a movement toward isolationism over collective action. Given significant global health R&D funding comes through foreign aid budgets and the necessity of collaborative global action to deliver the cures of tomorrow, these developments are worrisome. Will these trends threaten progress, or will momentum continue? That’s a question we’ll surely continue to reflect on for many UNGAs to come.