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 week, the National Institute of Allergy and Infectious Diseases awarded Kephera Diagnostics two Small Business Innovative Research grants, totaling $5.7 million, for the development and testing of immunoassays for Lyme disease and Chagas disease. The company’s Lyme disease immunoassay could simplify diagnosis by eliminating the need to perform one of the two steps now used in the screening and confirmatory testing process. Kephera’s immunoassay for Chagas disease is designed to monitor treatment response in patients, as current drugs vary in efficacy in adults with chronic infections. It is being developed both for laboratory use and use in the field.A phase 1 trial evaluating a novel preventive HIV vaccine candidate, VIR-1388, has begun enrollment in the United States and South Africa. VIR-1388 is designed to prompt the immune system to produce T cells that can recognize and signal an immune response to prevent the virus from establishing chronic infection. It delivers vaccine material using a cytomegalovirus (CMV) vector, whose discovery and development was funded by the National Institute of Allergy and Infectious Disease (NIAID). Because CMV, while harmless, remains detectable in the body for life, researchers hope this vector will help the body retain the vaccine material for a longer period of time, overcoming the waning immunity seen with other candidate vaccines. The trial is sponsored by Vir Biotechnology with support from NIAID and the Bill & Melinda Gates Foundation.Last week saw the launch of a third phase 1 clinical trial of the ChAdOx1 vaccine candidate for Middle East Respiratory Syndrome (MERS). If eventually approved, the vaccine would be a game-changing tool against the viral illness, for which there are no approved vaccines or treatments, and which is recognized by the World Health Organization as a priority pathogen with epidemic potential, especially in light of new cases reported this year. The University of Oxford’s Pandemic Sciences Institute started developing the vaccine for MERS before the COVID-19 pandemic, and the research for ChAdOx1, which was put on pause during the pandemic, enabled the rapid development of the Oxford/AstraZeneca vaccine for COVID-19.

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 US Food and Drug Administration (FDA) has given 510(k) clearance to the BD Respiratory Viral Panel, an automated, multiplexed, and real-time PCR test that can be used to detect COVID-19, influenza A and B, and respiratory syncytial virus (RSV) from only one sample, which was developed with support from the Biomedical Advanced Research and Development Authority (BARDA). The panel runs on a BD system widely used by hospitals and labs across the United States that can process hundreds of samples a day and deliver results in two hours. By reducing the need for multiple tests to distinguish the cause of respiratory infections, the test will help patients receive appropriate care faster and reduce burdens on the health system, which is important as the United States faces the rising threat of these viruses over the coming months.FDA is expected shortly to approve updated versions of the COVID-19 boosters, which although originally designed to target the XBB.1.5. omicron subvariant should still protect against the currently circulating subvariants, as cases and hospitalizations linked to the new variants rise. While it remains unclear whether the agency will grant emergency use authorizations or full approval licenses, either will trigger the Centers for Disease Control and Prevention to make its recommendations for who should receive the shots, allowing vaccinations to likely begin soon in the United States.Ghana recently became the first country in Africa to manufacture a cholera vaccine. The private-sector pharmaceutical consortium DEK Vaccines Limited produced the vaccine, as well as six others, including against malaria, HPV, pneumonia, and rotavirus, which are expected to be available by 2026. This was made possible through a licensing and technology transfer agreement with the International Vaccine Institute (IVI). Scaling up local production of vaccines is seen as an important step toward enabling Ghana, the West African region, and the continent at large to reduce the critical shortage of vaccines and reliance on foreign countries and companies and to ensure greater access to vaccines that protect against endemic diseases.

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 month, Brazil became the first country in the world to introduce tafenoquine, the first new single-dose treatment for P. vivax malaria developed in 70 years. Tafenoquine, developed by GSK and Medicines for Malaria Venture (MMV) in partnership with local researchers in Brazil, improves upon the previous treatments, which had major issues with adherence due to higher complexity and longer duration. The local Brazilian research partners also developed a new point-of-care test to identify a hereditary condition that can cause hemolytic anemia in those who take tafenoquine or one of the previous treatments, primaquine. After the approval and registration of tafenoquine in Brazil in 2019, field studies conducted over the last few years found extremely high levels of compliance with the new treatment protocol of routine testing to inform treatment, and similar feasibility studies are starting around the world, which will hopefully provide further evidence to improve global and national malaria guidelines and programs.The world’s first trial for a potential treatment for Crimean-Congo hemorrhagic fever has launched in Turkey. There are currently no specific approved drugs or vaccines and limited funding for R&D for the virus, which was named a priority pathogen by the World Health Organization. It is endemic in many countries in Africa, the Middle East, and Asia and has a mortality rate as high as 40 percent. The phase 1 trial will test the safety and potential dosages of two different drugs in multiple combinations, hopefully leading to more advanced trials or at least initiating momentum for more research to address the virus.This week, the US Food and Drug Administration approved a monoclonal antibody, Beyfortus, to protect infants and young children from respiratory syncytial virus (RSV). The single-injection antibody therapy, developed by AstraZeneca and marketed in the United States by Sanofi, showed strong results in phase 3 clinical trials. If the treatment gets a further recommendation from the Centers for Disease Control and Prevention, the drug could greatly reduce hospitalizations and deaths caused by RSV, which is the leading cause of hospitalization of babies in the United States. Beyfortus, has already been licensed in the European Union, the United Kingdom, and Canada, and other technologies for RSV, including a vaccine for pregnant people are also aiming to reduce the global burden of the virus.

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 (WHO) published its first global research agenda outlining key priorities in the fight against antimicrobial resistance. The intent of the agenda is to provide researchers, policymakers, funders, and other stakeholders with priority research topics for which greater action and evidence is needed. It covers issues including preserving current antimicrobials, advancing point-of-care diagnostic tests, and developing novel drugs to treat drug-resistant infections. The 40 priorities that relate to prevention, diagnosis, treatment and care, and cross-cutting topics were developed after a review of more than 3,000 documents published over the past decade looking at antimicrobial resistance.A recent study found promising results for a new, point-of-care genomic test for human papillomavirus (HPV) that could be a cheaper and more accessible option for cervical cancer screening in low-resource areas like sub-Saharan Africa, which has the highest rate of deaths from cervical cancer globally. Unlike currently available screening options, the HPV DNA test can be performed by a health care professional with minimal training using a mini centrifuge in the lab, cutting out the need for robust laboratory infrastructure and highly skilled professionals. The research team behind the test is now trying to make the test even more effective and efficient in low-resource settings by making it faster, inclusive of more HPV genotypes, and more sensitive.Researchers from the University of Montreal recently published a study showing for the first time the crucial role of a protein, adyl hydrocarbon receptor, or AhR, in allowing HIV to remain latent in the body, thus requiring antiretroviral therapy to be maintained in order to keep the virus from replicating. The researchers used CRISPR technology and drugs to neutralize the activity of AhR and observed that viral growth occurred in people living with HIV and on antiretroviral therapy. The study proposes a “shock and kill” strategy that would use drugs to inhibit and then reactivate AhR in the presence of AhR inhibitors to expose the HIV-infected cells for the immune system to then target and kill. Investigators hope further research can validate this method of fighting HIV.