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Researchers examine onchocerciasis (river blindness) diagnostic tests. PATH/Patrick McKernWithout the right diagnostics, we can’t effectively treat diseases. It’s an obvious statement. But in many low- and middle-income countries, doctors and health care workers don’t have access to the diagnostic tools they need, often because existing tests are too costly and not appropriate for low-resource settings or tests don’t exist at all. Without the right tests, doctors end up relying on patient symptoms, which can be remarkably similar across different diseases. The result can be devastating: A wrong diagnosis can lead to the wrong treatment or a failure to recognize the presence of disease with pandemic potential. This problem is a common one: in half of African countries, more than 80 percent of those treated for malaria receive medicine without confirmation of a diagnostics, and during the 2014–2015 Ebola outbreak, efforts to contain the outbreak were hampered by a lack of rapid, point-of-care tests that could be deployed easily in the field.In a recent New England Journal of Medicine article, a group of scientists and doctors suggested an innovative idea to improve global access to critically-needed diagnostic tools: create a list.More specifically, they’re calling for the creation of an essential diagnostics list to complement the World Health Organization’s (WHO) Model List of Essential Medicines (EML). The EML provides guidance to countries on what drugs, therapies, and treatments should be made available to citizens to meet basic public health needs. Likewise, an essential diagnostics list would provide guidance on the vital diagnostics tests that should be available in each country, depending on its disease burden. In this way, the two lists would support and complement each other, with the diagnostics list identifying the tests needed to enable appropriate use of medicines on the EML.The transformative potential of an essential diagnostics listThe authors of the article have detailed the many ways an essential diagnostics list could be a transformative force for improving diagnostic capacity and access. By setting global guidance on the diagnostics tests recommended to countries to address basic health needs, an essential diagnostics list could provide a forceful policy argument for governments to invest in making existing diagnostics more broadly available. A list could also encourage governments to make further improvements to health systems to support diagnostic use, including laboratory training programs and strengthening health infrastructure and supply chains.But what GHTC is most excited about is one of the lesser-discussed aspects of an essential diagnostics list: its potential to catalyze research and development (R&D) of new diagnostic tools. A patient gets tested for malaria. PATH/Gena Morgan Diagnostic R&D is a significantly underfunded area of research, accounting for less than 5 percent of global funding of neglected disease R&D. The result is a lack of diagnostic tools targeting the specific health needs of low- and middle-income countries, such as easy-to-use platform technologies or rapid, point-of-care tests that can be used in remote, rural clinics.By detailing which diagnostics are necessary to support health interventions on the EML, an essential diagnostics list would readily expose health areas where we today lack appropriate and effective tools. In this way, the list could signal to product developers, industry, and donors where funding and attention is needed to facilitate diagnostic R&D.The impact of improved diagnostic access and capacity would be considerable: better care and treatment for patients, reduction in the inappropriate use of medicines which is contributing to drug resistance, and improved ability to detect emerging diseases like Zika and Ebola early before they become epidemics.Joining the call for an essential diagnostics listOn Wednesday, GHTC sent a letter, signed by 11 of our member organizations, to WHO’s assistant director-general for Health Systems and Innovation calling for WHO to spearhead the creation of an essential diagnostics list. Given WHO’s experience in administering the EML and its ongoing work in providing guidance on diagnostic testing and laboratory accreditation; we believe the organization is uniquely positioned to lead on the development and implementation of this list. But making this initiative a reality will require the support of civil society and member states, as well as additional funding to stand-up the program at WHO.It is clear that treatment can be improved with essential diagnostics—ones we have today and others yet to be developed. We urge WHO and its member states to heed this call to establish an essential diagnostics list. It’s a smart, cost-effective idea that could advance diagnostic R&D and access.Update: On November 18, Dr. Marie-Paule Kieny, WHO Assistant Director-General for Health Systems and Innovation, replied to GHTC's letter indicating that WHO is pursuing analysis of the idea and outlining next steps. GHTC will continue to monitor progress and engage with WHO in support of this initiative.

Researchers at the US National Institutes of Health (NIH) have developed a test that can rapidly screen chemical compounds for their ability to treat drug-resistant infections. The team at NIH has already put the test to use, evaluating approved medicines, promising compounds, and drug combinations against common drug-resistant bacteria. After screening an estimated 4,000 drugs and compounds, the researchers identified 25 that effectively killed drug-resistant Klebsiella pneumoniae in the lab, including not only antibiotics, but also antifungals, antivirals, antiseptics, and even anticancer medicines. The test has also revealed three drug cocktails—each comprised of three different medicines—that can effectively treat ten common multidrug-resistant bacteria. These findings will enable clinicians to prescribe drug combinations with near certainty that they will treat a drug-resistant infection without waiting on lab results. While the tool is not yet commercialized, it can be mobilized to rapidly respond to emerging drug-resistant infections. A new study has revealed that during the 2014–2015 Ebola outbreak in West Africa, the virus evolved, enhancing its ability to infect humans. Previously, Ebola was thought by many scientists to be relatively static; however, researchers at the University of Massachusetts Medical School and University of Nottingham have independently identified a mutation in the Ebola genome—A82V—that appeared during the outbreak and could have made the virus two to four times more virulent. The mutation affects the cells on the surface of the virus that are responsible for infiltrating a host’s cells. For viral cells, shape matters, as it enables them to latch onto host cells like a key in a lock. The researchers suspect that A82V adjusts the shape of these surface proteins, allowing them to better fit into human cells. The mutation also enhances the virus’ ability to infect the cells of chimps and monkeys, while hampering its ability to infect bats, dogs, cats, rats, and mice. The team also discovered that patients with the new, mutated strain of Ebola were 27 percent more likely to die. Further research is needed to confirm this finding. Last week, the NIH and the Walter Reed Army Institute of Research (WRAIR) initiated clinical trials of an experimental Zika vaccine—the first of five phase 1 trials evaluating the vaccine. The vaccine platform was first used by WRAIR in developing a vaccine against Japanese encephalitis, a fellow flavivirus. The Zika Purified Inactivated Virus (ZPIV) contains complete, inactivated virus particles that will not cause disease but train the immune system to recognize and mount a robust response to the Zika virus. In preclinical trials, the vaccine candidate successfully induced an immune response and protected animals against the virus. The five phase 1 clinical trials will test the vaccine compared to placebos in different doses and schedules, as well as in different populations, including individuals previously exposed to flaviviruses (including Zika, yellow fever, dengue, Japanese encephalitis, and West Nile) and dengue, individuals who have received yellow fever or Japanese encephalitis vaccines, and those who have received the NIH’s experimental DNA-based Zika vaccine.