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.Last Wednesday, GlaxoSmithKline (GSK) announced its two-drug HIV regimen, Dovato, was successful in suppressing the virus in patients over a 48-week period at the same level of a previous three-drug treatment in a late-stage trial. The study evaluated the effectiveness of Dovato in adults with HIV-1 virus, the most widespread strain, who switched to the regimen from at least a triple combination containing Gilead’s Vemlidy. GSK’s HIV drugs division, ViiV, noted that adults who used Dovato did not develop any resistance to the treatment. Dovato, a combination of dolutegravir and lamivudine, was approved in the United States in April for newly diagnosed patients. GSK already has a two-drug regimen, Juluca, on the market but only for HIV patients that have received prior treatment.Two experimental Ebola drugs, an antiviral called remdesivir and an antibody treatment called ZMapp, have been found to be effective in laboratory studies in treating the strain of the virus responsible for the deaths of more than 1,600 people in the current outbreak affecting the Democratic Republic of Congo (DRC). According to this new research performed by the Centers for Disease Control and Prevention, in laboratory studies both drugs inhibited the growth of the virus strain in human cells. These two treatments were developed based on strains from previous outbreaks, and this study was the first to test them on the strain causing the current outbreak, which researchers are calling the Ituri strain. According to the latest figures from the World Health Organization (WHO), the Ebola outbreak in DRC has killed 1,630 people with 2,418 total cases—making it the second biggest outbreak of the disease in history.On July 9, WHO published updates to two lists critical for global health: the twenty-first WHO Model List of Essential Medicines and the second WHO Model List of Essential Diagnostics (EDL). These lists help countries prioritize critical health products that should be available, accessible, and affordable in a health system. While the first EDL, developed in 2018, covered a limited number of priority diseases, the second list has expanded to include more noncommunicable and communicable diseases, consisting of 122 test categories. In this editorial piece, Dr. Madhukar Pai, Canada Research Chair of Epidemiology & Global Health at McGill University, explains what’s included in the EDL, what follow up is required by low-and middle-income countries (LMIC) to make the list work, and the LMIC investment required to develop the diagnostic tests and laboratories necessary to deliver on universal health coverage and to better detect outbreaks, antimicrobial resistance, and pandemics.

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 National Institutes of Health has launched a large clinical trial to assess treatments for preventing people at high risk from developing multidrug-resistant tuberculosis (MDR-TB). The study is comparing the safety and efficacy of a newer TB drug delamanid—one of the first drugs available specifically to treat MDR-TB and the first to exist in a child-friendly formulation—with isoniazid, a decades-old drug for TB prevention, in preventing development of active MDR-TB among high-risk individuals exposed to household members with MDR-TB. Study participants are considered at high risk if if they have latent TB infection, suppressed immune systems from HIV or other factors, or are younger than five years old. Study investigators hypothesize that delamanid will be a better prophylactic treatment than isoniazid in reducing the likelihood that at-risk household members of individuals living with MDR-TB will develop active TB. Existing treatments for MDR-TB are often toxic, poorly tolerated, expensive, and aren’t always available. The World Health Organization (WHO) estimated 460,000 people worldwide developed MDR-TB in 2017. According the Access to Medicine Index issued last month, which ranks the world’s 20 largest pharmaceutical companies on their efforts to improve access to medications for the world’s poorest, the industry has made remarkable progress in increasing access to lifesaving medicines, through efforts like drug donation and licensing patents to generic producers. However, according to the report, most of the progress made by the industry is limited to a few companies with their efforts too reliant on donor dollars. GSK has ranked first every year since the rankings began, with its score steadily rising each year. Dr. Jayasree K. Iyer, executive director of the Access to Medicine Foundation which releases the index, stated that two billion people still lack access to the products they need, implying progress on access has just begun. A new, rapid diagnostic test that can detect yaws—a debilitating bacterial disease spread through skin-to-skin contact causing skin lesions and ulcers—may reinvigorate efforts to eradicate the disease which affects thousands of the world’s poorest children. The molecular diagnostic test costs just US$2 and can detect yaws within 30 minutes at point-of-care, eliminating the time-consuming need to transfer disease samples to expensive high-tech labs. Though WHO reported more than 80,000 suspected cases of yaws in 2018, the real number of infections is likely to be much higher. The rapid diagnostic test is one of 30 finalists of the WHO Innovation Challenge and was showcased at the Africa Health Forum earlier this year. The diagnostic has shown “impressive results” in small trials, according to its creator, who is looking to do larger scale testing.

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. An experimental drug, remdesivir, was shown to protect monkeys against infection with Nipah virus—an emerging pandemic threat for which there is no approved vaccine or cure. The only current treatment is a still experimental monoclonal antibody that was tested during an outbreak in India last year. Remdesivir is also being tested against the Ebola virus in the current outbreak in the Democratic Republic of Congo and has shown some effectiveness against Lassa fever, MERS coronavirus, and respiratory syncytial virus in other studies. In the new study performed by the National Institute of Allergy and Infectious Diseases (NIAID) and the Centers for Disease Control and Prevention, eight African green monkeys were given lethal doses of Nipah virus. The four monkeys who received intravenous remdesivir within 24 hours of infection and daily infusions for 12 days survived, while the four that did not died within eight days. If remdesivir wins approval, “it will give us an extra treatment that could be used relatively quickly,” said Emmie de Wit, a virologist at NIAID, noting that “the average person who reaches a hospital dies within two days, so it’s hard to protect them once they’re infected.” The next step is to test how long after infection the drug can be given and still cure the animals. Women make up just over half of the 35 million people living with HIV worldwide but are underrepresented in clinical trials of potential HIV treatments, cures, and vaccines. A 2016 study performed by amfAR, the Foundation for AIDS Research, found that women represented a mean of only 11 percent of HIV cure trials, 19 percent of antiretroviral drug trials, and 38 percent of vaccine studies. Despite the well-known differences in how the immune systems of men and women respond to the HIV infection and how women respond to some drug treatments, clinical trials continue to rely heavily on the participation of gay men in particular. Further complicating women’s participation in clinical trials is the US Food and Drug Administration’s (FDA) strict rules for including women of childbearing age, leaving most researchers to opt for the easy way out and just enroll men, collecting data from women only after the drug is on the market. As scientists continue to pursue cures for HIV in light of reports of the second patient cured of the infection, researchers must reckon with the longstanding obstacle of the lack of women in clinical trials. The FDA has authorized the first diagnostic test to detect Zika antibodies in human blood to be marketed in the United States. The diagnostic, known as ZIKV Detect 2.0 IgM Capture ELISA, detects the proteins produced by the body’s immune system when it tests for the Zika virus in blood. Though 18 other active tests to detect Zika exist, they have only been allowed under emergency use. This newly approved diagnostic test will only be usable by those with clinical signs and symptoms of Zika or on those who have traveled to regions with active Zika transmissions. FDA Acting Commissioner Ned Sharples noted that the marketing authorization of this Zika diagnostic demonstrates “FDA’s work to protect the public health in emergency response situations.”

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. Last week, the World Health Organization’s (WHO) new Science Division unveiled a Health Product Profile Directory—an online resource to guide the research and development of new technologies to combat neglected diseases and other health threats, including antimicrobial resistance and diseases that pose a pandemic threat. The Health Product Profile Directory is a free, searchable database of target product profiles for needed health products to tackle the world’s most pressing global health issues. Each product profile outlines eight to ten key characteristics for development of various health products, including vaccines, medicines, and diagnostics. The directory currently contains 196 product profiles developed by 24 agencies, 91 of which are focused on infectious diseases. In this editorial piece, Dr. Madhukar Pai also discusses whether the product profiles should address affordability, the opportunity to leverage the directory to tap into the potential of emerging innovators in the Global South, and ways to improve the new WHO resource. Every year, 5.4 million people are bitten by snakes. Between 81,000 and 138,000 die as a result, and of those who survive, 400,000 suffer lifechanging injuries. Two years ago, WHO formally classified snakebite as a neglected tropical disease and later this month it will launch a global strategy aimed at halving the number of deaths and cases of disability caused by snakebite by 2030. Last week, two major funding announcements for snakebite research were made public. Wellcome Trust announced a new £80 million program to transform the way snakebite is managed globally, and the UK Department for International Development (DFID) released £9 million to fund the development of a universal snake antivenom. The DFID-funded consortium—which includes the International AIDS Vaccine Initiative, the Liverpool School of Tropical Medicine, and snakebite specialists from Kenya, Nigeria, the United States, and India—will leverage the technology and processes that led to the discovery of drugs to combat HIV to develop new antivenom therapies. It will run through 2021, when a pre-clinical prototype of antivenom is expected. TB Alliance was awarded a Center of Excellence in Translational Research grant by the National Institute of Allergy and Infectious Diseases to support the development of two new clinical stage tuberculosis (TB) drug candidates. The grant, spaced out over five years, will provide US$5.5 million in the first year and reach a total of $28.4 million by 2024. With this grant, TB Alliance and its research partners will focus on the development of compounds that address drug-sensitive and multidrug-resistant strains of TB. “Expanding the global portfolio of new TB drug candidates, from which we can assemble tomorrow’s shorter and simpler cures, is crucial in the fight against TB,” said Dr. Mel Spigelman, president and CEO of TB Alliance.