Breakthroughs Blog: Diagnostics

Malaria is one of the world’s oldest and deadliest diseases. Thanks to international efforts to develop and scale up prevention tools and treatments, significant gains have been made over the past few decades in fighting this dangerous disease. But challenges, such as growing drug and insecticide resistance and disruptions from COVID-19, have hampered control efforts. Unfortunately, in 2020, both malaria cases and deaths increased significantly from the prior year—indicating progress against the disease has stalled and underscoring the need for continued research and development of new tools.In recognition of #WorldMalariaDay, test your knowledge of this deadly disease and the innovations being advanced to #EndMalaria:

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 World Health Organization’s COVID-19 Technology Access Pool and the Medicines Patent Pool last week finalized a licensing agreement with the Spanish National Research Council (CSIC) for its serological antibody test, marking the first non-exclusive license for a COVID-19 health tool. The CSIC test—a serological antibody test that evaluates for the presence of anti-SARS-CoV-2 antibodies developed either in response to a COVID-19 infection or to a vaccine—is relatively simple and suitable for basic laboratory infrastructure. The new license will allow the test to be offered royalty-free to low- and middle-income countries in order to promote equitable access to COVID-19 tools and facilitate rapid manufacturing and commercialization of the tool worldwide. Last Monday, Pfizer and BioNTech announced their COVID-19 vaccine was 100 percent efficacious in preventing infection among 12- to 15-year-olds from seven days to four months after administration of the second dose. The new results come from a longer-term analysis of a phase 3 trial—so far the only disclosed longer-term data demonstrating the safety and efficacy of a COVID-19 vaccine in individuals 12 to 15 years of age. The vaccine has been authorized by the US Food and Drug Administration (FDA) for this age group since May and is fully licensed for individuals 16 years of age and older. The companies plan to submit the data to the FDA for an extension of their COVID-19 vaccine approval to cover the younger age group. The Coalition for Epidemic Preparedness Innovations (CEPI) plans to expand its centralized vaccine testing capabilities employed for COVID-19 to the development of vaccines for other epidemic and pandemic diseases. CEPI’s network, the world’s largest for assessing COVID-19 vaccines, comprises a global collection of labs, which more than 30 COVID-19 vaccine developers have used to access more than 15,000 clinical trial samples. The system will now be used to support vaccine development for other priority diseases, including chikungunya, Lassa fever, MERS, Nipah, Rift Valley fever, and Disease X. The testing network is intended to help quickly and accurately identify the most promising candidates with the best potential for late-stage clinical trial advancement and regulatory review, which also supports CEPI’s overarching goal of reducing the vaccine development timeline to just 100 days.

At GHTC, we get to read stories every day about incredible innovations in global health. Most of the technologies we see 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. Now, we’re testing how well you know these global health technologies with our annual Halloween game: the TRICK or TREATment quiz.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 is 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

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. A six-month oral treatment regimen for rifampicin-resistant tuberculosis (TB) is substantially more effective than the current standard of care, according to preliminary trial results presented at the 52nd Union World Conference on Lung Health on Wednesday. The TB-Practecal trial tested a six-month regimen of bedaquiline, pretomanid, linezolid, and moxifloxacin (BPaLM) among 552 patients against the locally accepted standard of care at seven trial sites across Belarus, South Africa, and Uzbekistan. Findings showed around 89 percent of patients in the BPaLM group were cured, compared to 52 percent in the standard of care group. Current standard care for rifampicin-resistant TB can require up to 20 pills daily, along with injections, for up to 20 months.A new fingerstick blood test could be a promising tool for screening TB patients, interim study results indicate. The test, developed by Cepheid, gives results in under one hour using a few drops of blood. The new results, from a study of 195 participants in Gambia, Uganda, South Africa, and Vietnam, show an overall sensitivity of 91 percent and specificity of 86 percent, regardless of HIV status or geographical location, which meets the World Health Organization’s minimum specifications for a TB triage test. Researchers plan to expand trials to further test the technology’s accuracy, including among people who have other risk factors for TB, as well for people who have both TB and COVID-19.On Friday, the US Food and Drug Administration (FDA) released a briefing document indicating the Pfizer-BioNTech COVID-19 vaccine is more than 90 percent effective against symptomatic COVID-19 among children ages 5 to 11. The data is based on a 10-microgram vaccine dose, a third of the dose used for adults and older children, which minimizes side effects but still induces a strong immune response. The antibody response was comparable to the one seen in individuals 16 to 25 years old, and no new safety problems were identified in the companies' studies. The FDA also released an analysis later Friday showing the protection “would clearly outweigh” the risks of the shot. FDA advisers will meet Tuesday to discuss expanding authorization of the vaccine, currently greenlit for people over 12, to those ages 5 to 11.