Breakthroughs Blog: Diagnostics

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Researchers at the 48th Union World Conference on Lung Health highlighted three promising innovations that have the potential to modernize the tuberculosis (TB) diagnostic and treatment landscape. The first innovation builds upon the current therapy monitoring protocol, which involves directly observing patients to ensure they take their medicines, in a novel and contemporary way. The new system, Remote Observation Therapy (ROT), uses an edible sensor and a wearable patch to remotely track whether patients are taking their TB medicine and assist public health professionals with treatment monitoring to ensure that patients continue and complete TB therapies. The second is an oral swab alternative to sputum tests. Current sputum tests are difficult to collect and pose various problems for patients who need to produce the sample. Instead, a simple cheek swab has delivered promising results, though the swab will still require analysis from a GeneXpert or a similar machine. Lastly, a new, rapid prototype blood test, which can detect TB in as few as 15 minutes and requires no electricity and limited medical training, is showing promise. This diagnostic tool would address a major gap in blood-based TB diagnostics. A new, oral therapy has shown promising results in clinical trials for curing sleeping sickness, a debilitating disease that affects the neurological system.. The oral drug—fexindazole—cured 91 percent of patients with severe sleeping sickness and 99 percent of patients in the early stages of the disease. Fexindazole is a much-needed alternative to current combination therapies that involve a mix of pills and intravenous infusions, which can be challenging to administer in low-resource settings where infrastructure and highly trained health workers may be limited. Wellcome Trust, with assistance from the UK government and the Bill and Melinda Gates Foundation, has announced the Global Burden of Disease Antimicrobial Resistance (AMR) project , a new research initiative to track global data on drug-resistant infections and deaths. Over four years, the project will compile relevant data, produce detailed maps for intervention and clinical purposes, and provide publicly available visual representations on AMR’s global burden. This project will allow governments and researchers to strategically target global efforts to combat AMR.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week.Sanofi, a major vaccine developer, ceased their Zika vaccine program, highlighting how difficult it is to develop an effective vaccine for Zika. The US Biomedical Advanced Research and Development Authority reduced funding to Sanofi for the vaccine program last month, and Sanofi announced in early September it will no longer seek funding to continue its vaccine research. Smaller companies are in clinical stages of testing different Zika vaccine candidates, but Sanofi was the first major US pharmaceutical company to begin research on a potential vaccine for the virus. A female Culex quinquefasciatus mosquito (CDC/ James Gathany)The Infectious Diseases Data Observatory, a research observatory based out of the University of Oxford in the United Kingdom, is developing a data-sharing platform to compile and share Ebola data to aid in the response to future outbreaks. Researchers are seeking to engage local African leaders in the platform's creation to provide cultural context and ensure the resulting system improves the capacity of African researchers to conduct research in outbreak scenarios. Organizers agree that developing the platform now—during a period of no active outbreaks—is critically important, as having the platform available for aid workers and medical professionals before the next Ebola outbreak may aid in saving lives. A new, low-cost tool has been introduced in disadvantaged areas to treat newborn asphyxia. Newborn asphyxia is highly prevalent in low-resource settings, with about 20 percent of all newborn deaths in India caused by the condition. Therapeutic hypothermia—which reduces an infants body temperature—is a common treatment, but hypothermia-inducing machines are typically too costly for low-resource settings. Dr. Niranjan Thomas of Vellore, India created the MiraCradle, a fast-acting, low-cost device made of several phase changing materials—substances that absorb and release thermal energy—that is used as a regulation agent to keep a newborn hypothermic. The MiraCradle is currently being used in about 125 hospitals throughout India and South Africa.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Scientists at the National Institutes of Health’s National Institute of Allergy and Infectious Diseases have developed a Zika transmission model using mice in order to model the virus’ transmission from human-to-human. While humans are naturally more susceptible to contracting Zika than mice are, scientists were able to use genetically modified mice to validly mimic the transmission. Scientists found that while vertical transmission is possible from mother to fetus, some of the fetuses were not infected with the disease, suggesting the placenta is capable of being an effective barrier to the disease. They also found that Zika can be found in the lymph nodes, suggesting the virus can infect more areas of the body than previously thought. The World Health Organization has provisionally recommended the use of a new insecticide bed net, the Interceptor G2, which is capable of killing up to 75 percent of mosquitos that have become resistant to a common insecticide. The Interceptor G2 bed net combines two different insecticides: pyrethroid, which is currently used in insecticide-treated nets, and chlorfenapyr, an insecticide previously only used in agricultural settings. Studies in sub-Saharan Africa have yielded promising outcomes, with the nets remaining effective even after having been washing up to 20 times. Three studies recently published in Emerging Infectious Diseases found new treatments against multidrug resistant (MDR) and extensively drug resistant (XDR) tuberculosis (TB) are delivering positive results. The largest study focused on a year-long delamanid treatment for 53 MDR-TB patients. Following treatment, 73.6 percent had a favorable response, with 67.6 percent of participants having multiple negative TB cultures. The second study analyzed bedaquiline therapy on 27 children with both MDR- and XDR-TB, and found that of the 23 children that remained a part of the study over the year, all had negative cultures. The third study was retroactive, with researchers observing combined bedaquiline and delamanid therapies in XDR-TB patients. In a total of five participants, researchers found one was culture negative, three were continuing treatment, and one had died. While these studies all have small sample sizes, preliminary data suggests these drugs have a high efficacy in treating resistant strains of TB.

What do an onsite chlorine generator, fingerprint scanning technology for newborns, and temperature-monitoring wristband all have in common? The potential to save the lives of mothers and newborns in some of the poorest, hardest-to-reach communities around the world. These were among the many innovations pitched on July 27 at the DevelopmentXChange—the final stage of competition in the seventh annual Saving Lives at Birth: A Grand Challenge for Development, a prize program sponsored by the US Agency of International Development and other partners to identify and advance transformative, cost-effective solutions to improve maternal and newborn health, particularly during the first 48 hours after birth. Through the challenge, innovators compete for grants to develop, test, and bring their ideas to scale. This year, the challenge received more than 550 applications from across the world, with 53 teams chosen as finalists to compete at this year’s DevelopmentXChange. At the conclusion of the event, 15 winners were selected, with additional grant recipients to be announced later this year in the transition-to-scale category. GHTC members featured among finalists Among the 53 finalists were five promising innovations from GHTC member organizations, profiled below: Validation of an innovative, onsite, easy-to-use chlorine generator for infection prevention and control in labor wards* PATH The chlorine generator for infection prevention and control in labor wards. (Photo: GHTC/Marissa Chmiola)With just salt, water, and a power source, a hospital or clinic can create chlorinated water onsite to disinfect equipment and surfaces to keep mothers and babies healthy. That’s the idea behind the SE Flow Chlorinator—an easy-to-use, cost-effective chlorine generator designed for low-resource settings.  Infections are a leading cause of death for mothers and newborns during childbirth. While chlorine is one of the most widely-used and accepted methods for disinfecting surfaces, getting chlorine to remote health care facilities can be a challenge due to combination of weak supply chains, inconsistent transportation networks, and bureaucratic hurdles. The result: Close to one-third of facilities in low-income countries recently surveyed by the World Health Organization (WHO) did not have chlorine available. PATH and its partner MSR Global Health hope the SE flow will address chlorine supply chain hurdles by enabling facilities to produce consistently chlorinated water on the spot, at the quantity needed. The device also produces an additional benefit: cost savings. Over five years, the SE flow is estimated to save a facility 50 percent over the cost of purchasing chlorine on the market. PATH and MSR Global Health plan to test 50 of the devices next summary to collective evidence, refine the design, and support a broader roll out. Validation of an innovative newborn respiratory package of equipment and training* PATH Respiratory infections are a leading cause of infant mortality, particularly in premature infants whose lungs are not fully formed. Without strong lungs and appropriate oxygen intake, newborns face significant challenges in healthy development, including lifelong neurological damage or blindness. Continuous positive airway pressure (CPAP) therapy helps mitigate these challenges; however, the tools used in high-income nations to administer this therapy have traditionally been too costly to use in low-resource settings overseas.  A low-cost  bCPAP device for newborn health. (Photo: GHTC/Taylor Capizola) PATH and other partners developed a low-cost bubble CPAP (bCPAP) device, combined with an oxygen blender, that is appropriate for low-resource settings and has proven effective in controlling the flow of air to support breathing. To support further uptake and effective use of this intervention, PATH is now partnering with the Massachusetts General Hospital Division of Global Health and Human Rights to package the bCPAP, oxygen blender, nasal prongs, and a pulse oximeter with training and educational materials, including checklists, manuals, and wall charts. The training materials will be essential to expanding newborn access to respiratory therapy, particularly in facilities where no prior intervention existed and medical staff may be uncertain of how to best use these new tools. The team has also partnered with Sinapi biomedical, a South African biomedical manufacturer, to manufacture the package of tools and training materials to greatly expand the number of medical facilities using these interventions by bring the toolkit to scale. They expect that with Saving Lives at Birth support, mortality will drop 25 percent among newborns treated in facilities introducing bCPAP therapy for the first time. Building social accountability structures for respectful maternity care in Kenya: “RMC Virtual Space” Population Council Population Council's virtual space photos. (Photo: GHTC/Marissa Chmiola)The birth of a child can be one of the most moving experiences of a mother’s life, but in many low-income countries, it can also expose a woman to abuse and disrespect. Women who visit a health care facility during childbirth often face mistreatment, whether in the form of physical abuse, non-consent for physical examinations, neglect, or disrespectful comments. Often women are hesitant to report these incidents due to fear of reprisal or distrust that their feedback will be heard. Population Council has designed a low-cost mobile text message reporting platform that they believe will empower women to report their experiences and help providers comprehend the scope of the problem and develop solutions. This intervention works by enrolling women in the platform when they visit a facility for care. Following a visit, the patient is prompted through text message with a series of simple questions to collect information about her experience. The data is then aggregated and presented to the provider or facility in an easy-to-understand, dashboard-style system. Population Council chose to design the platform using text messaging as the basis for collecting feedback because it is ubiquitous across the African continent and provides a level of anonymity that encourages women to report their experience. The project team is at the concept stage and is currently testing the intervention in health facilities in Kenya to solicit feedback and refine its approach. Innovative packaging and pasteurization for donor human milk to improve health outcomes for preterm infants PATH Human milk banks play a critical role in ensuring that safe, high-quality human milk can be made available to infants whose mothers are unable to directly provide their own milk. Current guidelines for human milk pasteurization require temperature control of 62.5 degrees Celsius for 30 minutes to ensure all pathogens and bacteria are killed. Unfortunately, while this temperature kills microorganisms that can make infants sick, it also kills vital nutrients for an infant’s growth and development. No further international guidelines have been established, leaving engineers and scientists with the challenge of delivering safe, yet properly nutritious donor milk to milk banks. To solve this issue, PATH is seeking to improve the two processes involved in transporting human milk to milk banks: Pasteurization and packaging. PATH plans to research and narrow in on the optimal temperature range and timing capable of keeping human milk safe to drink and properly nutritious for infants. As part of this, PATH is also exploring the most effective packaging that help in achieving this temperature range and timing. Currently, the most common packaging for human milk is plastic or glass jars, but PATH researchers have found these jars do not transfer heat well or consistently. PATH plans to test a number of packaging options from stainless steel jars, which are commonly used in countries like India, to sterile plastic bags coated in aluminum—which in early testing have shown to distribute heat evenly and are easy to transport. Once the optimal temperature rage and optimal packaging are discovered, PATH plans to distribute this information widely to milk banks, donor human milk pasteurization equipment manufacturers, and human milk packagers to improve health and survival outcomes for all infants who receive heat-treated donor human milk globally. Advancing a simple, low-cost rapid diagnostic test for urinary adipsin: A promising new biomarker-based test for improving preclampsia screening in low-resource settings* PATH The preeclampsia (PE) test. (Photo: GHTC/Matt Robinson) Preeclampsia (PE) is a dangerous condition that causes organ failure and seizures, and it is one of the leading causes of maternal and newborn deaths worldwide. While diagnostic tests already exist that can provide early warning of risk factors, accurate tests require samples collected over 24 hours, and rapid tests were able to identify only 51 percent to 68 percent of risk cases. Thanks to a Saving Lives at Birth Round 4 Seed Award, PATH has developed an early prototype of a rapid diagnostic test (RDT) that is just as fast as existing RDTs, but is capable of catching 85 percent of risk cases early in the third trimester of pregnancy in plenty of time to take action. It is also temperature stable at 37 to 45 degrees Celsius and can be produced for pennies on the dollar of the cost of previous tests.  With its round seven award, the PATH team will undertake additional activities to bring the new RDT closer to broad scale use. First, the team will further optimize the test to expand its shelf life and determine the feasibility of increasing the test’s accuracy. Second, the team will explore whether the test—which currently requires a strip be dipped into urine in a separate container—can be incorporated into a form similar to at home pregnancy tests, making it easier to use and allowing women to take the test in the comfort of their own homes. Finally, the team will begin negotiations with commercial partners to scale up the product so it becomes widely available worldwide. The transformative power of innovation GHTC congratulates both our members and the other teams who were selected as finalists and award winners. This year’s prize winners will join the growing community of over 100 innovators supported by the Saving Lives at Birth partnership. Many of these innovations are beginning to have an impact as they are brought to scale. To date, the program has supported 1.5 million women and newborns and saved nearly 10,000 lives. The Saving Lives at Birth program proves that through creative partnerships and innovative ideas and interventions, we can create dramatic improvements in the health and well-being of people around the world. *indicates this intervention was among the 15 winners. GHTC staff including Taylor Capizola, program assistant; Matthew Robinson, MA, multilateral advocacy and policy officer; and Courtney Carson; US advocacy and policy officer, contributed to this article.