Breakthroughs Blog: Diagnostics

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.

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. Two new studies at Scripps Research have shown how human and mice antibodies can bind to and stop the infection of all five types of Ebolavirus—a key step in developing therapeutics capable of neutralizing all variants of the virus. During the studies, scientists observed the ability of a human antibody called ADI-15878 to bind directly to the viral “fusion loop,” which the virus uses to fuse with human cells to initiate infection, making it impossible for the virus to enter into human cells. Discovered in a human Ebola survivor, ADI-15878 is the only known antibody ever found to neutralize all five strains of the Ebola virus. A new study shows the potential of a novel microneedle platform to be used to administer vaccines during a pandemic. Researchers created a unique prototype vaccine that combined different technologies including: tiny microneedles that penetrate only the upper of the skin, a version of the H5N1 vaccine made from noninfectious “virus-like” particles that can be rapidly produced in tobacco plants, and an ingredient called an adjuvant that speeds up and strengthens the body’s response to the vaccine and has demonstrated protection against related viruses. While the study showed the product was effective in ferrets and appeared safe in humans, large-scale human trials are still needed. As vaccine researchers search for new approaches to combat pandemics, this prototype could lead to vaccine patches that could be distributed rapidly and administered without a nurse. Scientists plan to test the efficacy of a Zika vaccine candidate by intentionally infecting people with the virus, a strategy known as a human challenge trial. Researchers first launched the vaccine trial in March 2017 following an outbreak of the virus in the Americas in 2016 and had planned to open new trial sites in infection hot spots, but the effort is currently in limbo given the significant drop off in Zika cases. A major concern of researchers is that those participating in the trial may never be exposed to the virus, making it impossible to determine if the vaccine works. Plans to conduct a human challenge trial for this Zika vaccine candidate were halted by an ethics committee in 2017, which worried that people intentionally infected with the virus might transmit it to their sexual partners. Now, this method is being considered again as cases drop and industry loses interest in bringing a vaccine to market.

For many mothers and babies around the world, the first 48 hours after birth are the most dangerous of their lives. For eight years, Saving Lives at Birth—spearheaded by USAID—has challenged problem solvers worldwide to create innovative solutions to make birth safer and save lives. Here are ten incredible innovations from this initiative: Many newborns struggle to breathe. While in developed countries, doctors use CPAP machines, these devices are too costly for most health facilities in low-resource nations. Fortunately, innovators at Rice University have developed a low-cost solution—the Pumani bCPAP. Delivering comparable treatment at 1/15th the cost, the Pumani has tripled the survival rate of babies with respiratory distress.   Blood pressure (BP) disorders like pre-eclampsia are a leading cause of maternal death. BP cuffs have been used to monitor BP since the early 1900s, but they can be hard to maintain and read by less-skilled health workers. A startup named Biospectal is reinventing this approach. It has developed the OptiBP, a cuff-less smartphone app that allows instant, accurate BP monitoring through a fingertip.   Affecting 60% of newborns, jaundice can cause brain damage or death if left untreated. In low-resource nations, doctors often don’t have access to costly lab equipment needed to diagnose the disorder. That’s where the BiliSpec comes in. Developed by Rice University, this handheld, battery-powered device can diagnose jaundice within two minutes using just a $0.05 paper strip and a drop of blood.   Even a small dip in a newborn’s temperature can put her life at risk. Continuous temperature monitoring is key to detecting issues early, but in overcrowded health facilitates, it can be hours between readings. To address this gap, Rice University developed the Neonatal Temperature Monitor—a simple, affordable tool to continuously monitor and display infant temperature, alerting staff of problems.   Malaria during pregnancy is dangerous for both mothers and their unborn babies. Researchers are studying whether a promising new malaria vaccine candidate—Sanaria’s PfSPZ vaccine—could offer a solution. The research team will test the vaccine in pregnant women and monitor the mothers and newborns post-birth. If successful, the project could radically change malaria management in pregnant women.   Poor water and sanitation in low-resource health facilities can expose moms and babies to infection at birth. Chlorine is a commonly used disinfectant, but supply chain issues make it hard for facilities to ensure a steady supply. PATH and MSR Global Health created an innovative, low-cost tool—the SafiStation Chlorine Generator—to produce chlorine on site using just water, salt, and electricity.     While stillbirths are common in poor regions, increasing evidence suggests that non-breathing newborns are often misidentified as stillborn when they have heart rates (HR) and could survive with resuscitation. To address this gap in care, researchers developed the NeoBeat, a low-cost, belt-like device that takes seconds to put on a baby and provides a continuous digital display of newborn HR.   Jaundice is common among newborns. Fortunately, if found and treated early it is also curable. To facilitate diagnosis and treatment in low-resource areas, innovators developed the Bilikit, a comprehensive package of low-cost tools to manage jaundice. The kit includes the Bilistick, a rapid, hand-held, portable diagnostic device, and the Bili-Hut, a portable, high-intensity phototherapy device.   Blood donation shortages in Africa can leave health workers with few options if a woman is hemorrhaging blood during childbirth. Attendants often resort to using a soup ladle and gauze to try to salvage and recycle a patient’s own blood. The Hemafuse pump by Sisu Global Health is a cost-effective, hygienic alternative. This tool sucks up blood, filters it, and transfers it to a bag for reuse.   Over 100,000 women die annually from postpartum hemorrhage (PPH) or excessive bleeding. PPH is treatable, but the tools widely used to control dosage are too costly or infrastructure intensive for low-income nations. That’s a problem Shift Labs hopes to solve with DripAssist—a low-cost, battery-powered tool that constantly monitors medicine flow via an IV drip, sounding an alarm if it fluctuates.   View as a video below: Photo credits: PATH/Doune Porter; Pumani bCPAP: 3rd Stone Design, GHTC; OptiBP: GHTC: Bilispec: Rice University, 3rd Stone Design; Neonatal Temperature Monitor: GHTC; PfSPZ vaccine: Leiden University Medical Center, GHTC; Safistation: PATH/Adam Drolet; Neobeat: Laerdal; Bilikit: GHTC, Bilimetrix srl Trieste, USAID, Little Sparrow Technologies; Hemafuse: Sisu Global Health; DripAssit: Medgadget, GHTC

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 this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. In the past year, outbreaks of high-fatality diseases and pathogens such as Ebola, MERS, Zika, Nipah virus, Lassa fever, and Rift Valley fever have caused at least 190 deaths and cost millions. While these outbreaks have remained relatively contained, health officials warn these diseases all have the potential to strike again and cause a global epidemic that could kill thousands, wreak economic havoc, and threaten global security the world over. According to experts, the lack of investment in research and development is contributing to this risk. The technology company Univercells has raised over US $18.8 million in series B funding to support continued development of its platform to manufacture cost-efficient biologics. This comes on the heels of positive results from a pilot program of the company’s affordable vaccine manufacturing platform. The pilot, which tested production of the Sabin inactivated polio vaccine, showed the platform could delivers 43 million doses of the vaccine per year at a cost of US $0.15 per dose—considerably lower than current versions on the market. Univercells’ backers believe these two manufacturing platforms have incredible potential to make biologics and vaccines more affordable and accessible worldwide. The World Health Organization declared in May that Nepal has eliminated trachoma as a public health problem. Trachoma, a bacterial infection that causes swollen and inverted eyelids, is the world’s leading cause of blindness with approximately 190 million people in 41 countries at risk worldwide. Nepal follows in the footsteps of Cambodia, Laos, Mexico, Morocco, Oman, and Ghana in a list of countries that have eliminated trachoma since a global campaign to eliminate the disease was launched twenty years ago. Annual administration of antibiotics in at-risk areas and improved hygiene practices have helped drive this progress.