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. 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.”

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 first all-oral drug for sleeping sickness received a positive scientific opinion Friday from the European Medicines Agency, paving the way for the treatment to be rolled out in endemic countries in 2019. Developed by the Drugs for Neglected Diseases initiative (DNDi) and Sanofi, fexinidazole is a tablet taken once daily for ten days that treats the most common form of sleeping sickness, a neglected tropical disease spread by tsetse flies that causes neuropsychiatric symptoms and can be deadly if left untreated. Current treatments for sleeping sickness require a complicated series of infusions and pills, are costly, and involve long hospital stays, which pose a huge burden on health systems to treat the disease. Fexinidazole is a simple once-a-day pill that could reduce this logistical burden. About 65 million people in sub-Saharan Africa are at risk of sleeping sickness. A novel device colloquially known as a “wiggle- ometer” may one day help physicians and health workers fight the growth of antimicrobial resistance (AMR). The device, which is a sub-cellular fluctuation imaging machine, detects minute movements in bacteria to determine whether they’ve been affected by an antibiotic, signaling to doctors whether a specific antibiotic works against a specific infection. Today, many physicians prescribe a broad-spectrum antibiotic to patients because of the lack of access to rapid diagnostic tests to determine the nature of an infection and what antibiotics will be effective against it. This overuse and misuse of antibiotics drives the growth of AMR. The “wiggle-ometer” is one of more than 70 projects from around the world competing for the £8 million Longitude Prize, launched by the United Kingdom government to fight AMR. The prize will be awarded to a team that develops an affordable, accurate, easy-to-use test for bacterial infections. Merck has begun the process of submitting the evidence required for regulatory approval of its experimental Ebola vaccine with the US Food and Drug Administration (FDA). The FDA gave the vaccine a “breakthrough therapy designation” in 2016—a form of regulatory fast track which allows a manufacturer to meet more frequently with the FDA to discuss filing and to submit material on a rolling basis, all with the aim of speeding the item through licensure. Merck’s experimental Ebola vaccine is currently being used in the Ebola outbreak in the Democratic Republic of Congo under compassionate use protocol, after having shown to be protective in a clinical trial in Guinea at the end of the West African Ebola outbreak of 2014-2016. Though there are a few experimental Ebola vaccines in development, Merck’s is furthest along in development. Merck initially planned to file with the FDA in 2017 but missed that goal due to “unexpected engineering and construction delays” at the manufacturing plant built to produce the vaccine. Merck now says it hopes to complete the filing process sometime next year.

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