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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. On Monday, the US Food and Drug Administration (FDA) gave an Emergency Use Authorization (EUA) to a point-of-care COVID-19 antigen test developed by Becton, Dickinson and Company (BD), a GHTC member. The test—one of several COVID-19 diagnostics that BD has been working on—detects infection by scanning for proteins found on or inside the virus. The hand-held device provides results in about 15 minutes and runs on a BD diagnostics platform widely used across the United States. The relative speed of production and low cost of the rapid test make it an important tool in fighting the pandemic, according to FDA. BD has said it expects to produce 10 million tests by the end of September and 2 million tests a week thereafter.University of Oxford researchers are developing a rapid COVID-19 test that would cost less than US$25. The viral RNA test uses RT-LAMP technology and provides results from a throat or nasal swab within 30 to 45 minutes. The RT-LAMP technology requires no specialized equipment, scientific training, or a cold chain, which makes the device ideal for use in low- and middle-income countries that have less technical infrastructure. The test has gone through clinical validation, results of which researchers said would be published soon. Oxsed Limited, a new company launched by Oxford, will be pursuing its further development and market release.Newly released data demonstrates that an injectable form of cabotegravir is more effective than widely used oral drugs for the HIV prevention strategy of pre-exposure prophylaxis (PrEP). There are currently two FDA-approved PrEP drugs, both of which require daily oral intake. The new data, from trials conducted by the HIV Prevention Trials Network, shows that a single shot of cabotegravir every two months is 66% more effective than the most commonly used PrEP pill, Truvada. Viiv Healthcare, the company that developed the injectable drug, hopes to file for FDA approval in early 2021. The findings were presented by researchers during AIDS 2020, an annual international conference held virtually last week.

The Global Health Technologies Coalition (GHTC) condemns the US administration’s official notification to the United Nations secretary-general to start the process of withdrawing as a member of the World Health Organization (WHO). The United States helped found WHO in 1948 based on the understanding that diseases know no borders and that collective efforts to eradicate disease are better than any single country going it alone. WHO has been a valued partner in strengthening health research, product development, and regulatory systems globally. It plays a critical normative role in collecting health intelligence from around the world and helping support research advancement in HIV/AIDS, tuberculosis, malaria, neglected tropical diseases, emerging infectious diseases, antimicrobial resistance, and many other health areas. Looking at the current pandemic alone, WHO has played a herculean role in mobilizing the research response:It quickly developed target product profiles to guide global efforts to develop tests, treatments, and vaccines.It has marshaled a partnership with member states, major donors, and the private sector to create the Access to COVID-19 Tools (ACT) Accelerator to coordinate the development, manufacturing, and distribution of COVID-19 technologies. It is coordinating the Solidarity Trial, an unprecedented global effort to test potential treatments and vaccines, which includes the participation of over 100 countries and facilitates the comparison of potential therapeutic treatments 80 percent faster than single-country studies.It is coordinating safe and efficient Emergency Use Listings of COVID-19 products to support national regulatory agencies in reviewing products as quickly as possible when they become available and has created guidelines for developers who will seek approval of products through its prequalification program. It is developing a framework strategy for the distribution of future coronavirus treatments and vaccines, with over 4 billion doses needed to vaccinate the world's priority populations. Each element of WHO’s COVID-19 response touches the ongoing work of US government agencies, private-sector partners, researchers, and the academic community to collectively fight this pandemic.We urge Congress to engage with US agencies and other partners who work on health research and product development to request information on the myriad ways their work is advanced and strengthened through collaboration with WHO and how it might be negatively impacted by the Aministration’s decision. Remaining a member of WHO is in our health, security, economic, and scientific interests, and we once again call on Congress to take action and demand the Administration reverse this decision.