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. 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. 

Authored by Elodie Jambert & Elizabeth Poll, Medicines for Malaria Venture, Switzerland; Panayota Bird, GSK; and Dr Marcus Lacerda, Fiocruz, Brazil  The Amazon is a renowned hotspot for biodiversity, but it’s also a hotspot for malaria. Brazil is one of the Latin American countries with the heaviest burden of malaria, with its Amazon region accounting for 99.5 percent of all national cases. Tackling malaria in Brazil is complicated by the fact that the vast majority of the burden is caused by the malaria parasite Plasmodium vivax. After causing an initial bout of malaria symptoms, this species of parasite has the ability to hide dormant in the liver of infected people, only to re-emerge and cause symptoms again several weeks to several months after initial infection. Another compounding issue is that the only medicine currently available to stop such relapse is primaquine–a medicine approved in the 1950s that must be taken for at least seven days. Given this lengthy course of treatment, many patients fail to complete the full course. It’s a challenge to explain to patients why they should take seven days of pills to treat something that appears to have resolved after the third day (the duration of treatment of the initial acute P. vivax malaria bout). As a result, the medicine often doesn’t work, and transmission of relapsing malaria is perpetuated. In Brazil, over the last 20 years, the burden of the more deadly Plasmodium falciparum has fallen from 50 to 10−15 percent. Yet, progress against P. vivax is yet to see the same success; this parasite now causes 89 percent of malaria cases. While P. vivax doesn’t kill as many people as P. falciparum, it is still debilitating, can also be lethal, and has substantial economic impact on families and nations. As such, it’s important to keep the attention of policymakers focused on malaria even in the face of other pressing public health issues, such as Zika and chikungunya viruses.A new solution for relapsing P. vivax in sightChildren in the village of Boa Vista, on the border of the Juma Reserve in the Brazilian Amazon. Photo: Neil Palmer/CIATFortunately, a new solution to tackle relapsing P. vivax malaria could be in sight. Medicines for Malaria Venture (MMV) and GSK have collaborated to develop a new, single-dose anti-relapse medicine, tafenoquine. The medicine was submitted for regulatory review to the US Food and Drug Administration and Australian Therapeutic Goods Administration at the end of 2017. If approved, it could be an important new treatment for individuals suffering from relapsing malaria, and could help to eliminate the disease in the Amazon.MMV and GSK have developed an access strategy together with in-country partners and are preparing the ground for the medicine’s potential launch in endemic countries. Country-level briefings are ongoing with the National Malaria Control Programmes (NMCP) in Brazil and six other endemic countries (Thailand, Ethiopia, Vietnam, Cambodia, Peru, and Colombia); their goal is to assess interest in introducing the new medicine into national practice and to understand what type of evidence NMCPs would need to support policy adoption. Developing diagnostics to make anti-relapse medicines safer for allPATH rapid diagnostic test to support treatment and elimination of P. vivax. Photo: PATHIntroduction of tafenoquine faces one additional challenge: As is the case with primaquine, people with a genetic deficiency in a specific enzyme known as glucose-6-phosphate dehydrogenase (G6PD) can suffer potentially serious side effects. On average, 8 percent of people in malaria-endemic countries are deficient in this enzyme. To reduce the risk of patients suffering this side effect, PATH is supporting development of a point-of-care diagnostic test to identify patients’ G6PD status and determine whether tafenoquine or primaquine can be safely administered. Concomitant use of this point-of-care diagnostic test will be critical for the correct and well-tolerated use of tafenoquine. Despite the World Health Organization’s recommendation that G6PD tests guide the use of primaquine, few endemic countries routinely use such testing today. In Brazil, the prevalence of G6PD deficiency varies depending on the immigration profile of the region. Most published papers on the subject estimate that the average prevalence among men in Brazil is around 5 percent, a statistic recently confirmed with preliminary data from a government-supported prevalence survey in endemic areas of the Brazilian Amazon.In light of this, additional data is being gathered. Initial preparations for an implementation study are underway in Brazil to demonstrate how a quantitative G6PD test would work in practice, prior to use of tafenoquine in the healthcare system. It is planned for the study to begin after regulatory approval of tafenoquine is granted. The team is also working with academics to model the cost effectiveness of the medicine paired with a G6PD test compared to current standard of care (primaquine without a test), as well as the potential impact of tafenoquine on malaria transmission and elimination. The Brazilian government will use these findings as it considers broader deployment of the intervention throughout malaria-endemic areas.Tafenoquine has potential for significant impact both for the individuals that suffer from this disease as well as for the regions focused on malaria elimination. We await the regulatory decisions on the medicine and will continue to work together as a team of partners to prepare the ground in the Brazilian Amazon to help make it malaria-free for all.