Breakthroughs Blog: Diagnostics

A recent article explores how artificial intelligence (AI) could revolutionize the development of RNA drugs, which have emerged as a promising tool across health areas, from oncology to preventive vaccines. RNA-based therapies have demonstrated higher success rates than traditional pharmaceuticals and are associated with lower costs and much quicker drug discovery timelines. AI could help address current limitations of the technology by enabling faster and more accurate RNA target identification and expediting the testing of promising drug candidates, also leading to cost savings.  The World Health Organization (WHO) recently announced the prequalification of two rapid antigen tests for SARS-CoV-2, the virus that causes COVID-19, helping improve diagnostics access worldwide as the virus continues to circulate globally. The SD Biosensor Standard Q COVID-19 Ag Test and the Acon Biotech Flowflex SARS-CoV-2 Antigen Rapid Test were previously listed under the WHO’s emergency use listing. Their new designation makes them the first rapid antigen tests for SARS-CoV-2 to achieve WHO prequalification. This decision makes them eligible for procurement by United Nations agencies, global health partners, and other international stakeholders, helping ensure access to rapid, reliable diagnostic testing in low- and middle-income countries. A research team has used an innovative robotic system to develop a possible antibiotic candidate for priority bacterial threats, as the global danger of antimicrobial resistance continues to rise. Specifically, the researchers used the technology to rapidly screen more than 700 complex compounds in just one week, identifying a promising antibiotic candidate that demonstrated high effectiveness against bacteria, including strains similar to the deadly MRSA, while remaining non-toxic to human cells, suggesting it is a strong candidate for further drug development. The new process, which utilizes robotics and “click” chemistry, shows potential as a new method to expedite the typically slow drug discovery process. 

At the recent Union World Conference on Lung Health, TB Alliance presented the results of a Phase 2 clinical trial showing that the novel antibiotic candidate sorfequiline has the potential to improve tuberculosis (TB) treatment when combined with pretomanid and linezolid in people with drug-sensitive TB. The regimen was more effective than the current standard of care, and sorfequiline also demonstrated greater activity than bedaquiline, a key component of the BPaL regimen, a previous breakthrough that drastically reduced treatment time for most drug-resistant TB. This new treatment could shorten TB therapy even further. TB Alliance is working with partners ahead of the launch of a Phase 3 trial next year. Researchers at the University of California San Diego and partners have developed a new method to combat antibiotic-resistant bacteria, which could pave the way for developing alternatives to traditional antibiotics for treating a wide range of deadly infections, as the global threat of antimicrobial resistance continues to grow. The researchers used bacteriophages (or phages), which are viruses that infect and kill bacteria. Phages have been used to treat bacterial infections for more than 100 years but are usually limited in the bacterial strains they can successfully target. Researchers overcame this by allowing the pages to evolve alongside bacteria in a controlled laboratory setting for 30 days, enabling the phages to adapt their bacterial defenses, becoming more effective at killing a wide variety of bacterial strains, including drug-resistant ones, and better at suppressing bacterial growth for extended periods. Researchers at Indiana University have developed a molecular test that can simultaneously detect three dangerous fungi much faster than traditional methods, helping patients receive accurate, timely treatment against this growing global challenge. The test works by targeting genetic regions unique to each fungus, and it was much faster and more accurate than standard methods, a key advance as fungal infections are often mistaken for other respiratory illnesses. While the test still needs to be clinically validated in further studies, the research team believe it could eventually fill a major gap in fungal diagnostics. 

A team of chemists from the University of Warwick and Monash University has identified a promising, potent new antibiotic that seems to be much more effective than existing drugs against deadly superbugs like MRSA and shows no signs of resistance so far, encouraging news as the global threat of antimicrobial resistance continues to grow and the pipeline of new antibiotics continues to fall short. The molecule had been overlooked for decades as an intermediate chemical in the natural process to produce another known antibiotic, methylenomycin A, which was discovered 50 years ago, and despite having been synthesized multiple times, the synthetic intermediates have seemingly not been tested before for antimicrobial activity. The new antibiotic is much more potent than methylenomycin A itself—100 times more active against a range of serious bacteria. It could not only be a powerful new tool against rising drug resistance, but this work could also pave the way for new approaches to antibiotic discovery. A team of researchers has developed an antivenom using antibodies from a llama and an alpaca that can neutralize venom from some of the world’s most venomous snakes. Snakebites are a neglected public health issue that kill around 20,000 people in sub-Saharan Africa yearly. Current antivenom treatments are usually specific to a single snake species, and it can be difficult to identify which of the many types of venomous snakes is behind a bite, making timely, effective treatment difficult to achieve. The researchers exposed an alpaca and a llama to venoms from 18 of the most dangerous snake species in sub-Saharan Africa, isolated the antibodies that the animals produced against the venom, and then combined some of those antibodies in a single cocktail. In mice, the treatment protected against toxins from 17 African snake species and reduced skin damage. Many scientists previously thought that developing a broad-spectrum antivenom would require too many antibodies to be practical because some venom can contain up to 100 toxins, but this study shows that a combination of just a handful of antibodies can neutralize the venom of many snake species, paving the way for the development of similar broad-spectrum antivenoms for other areas where snakebites are a common public health challenge. Last week, Cepheid announced that its Xpert MTB/XDR test for tuberculosis (TB) drug resistance has been prequalified by the World Health Organization (WHO), enabling procurement through international agencies and greater access in areas with a high TB burden. The test is designed to detect resistance to multiple first- and second-line TB drugs from patient samples. It also delivers results quickly, within 90 minutes, allowing health care providers to make quicker, more reliable treatment decisions and have a better understanding of drug resistance, especially in regions with a high TB burden where timing and accuracy are critically important. 

A systematic review and meta-analysis of studies looking at the effectiveness of typhoid conjugate vaccines found that they are highly effective in preventing typhoid fever in countries where the infection is endemic, adding to the collection of real-world evidence supporting their use. Despite the high burden of typhoid fever—an infection caused by Salmonella enterica serovar Typhi—in Africa and Asia, only ten countries to date have added the vaccines to their national immunization programs. There are three vaccines for preventing typhoid fever that are currently recommended and licensed by the World Health Organization. Last week, California-based True Diagnostics announced that it had received an award of upward of $11 million from the Biomedical Advanced Research and Development Authority (BARDA) to support the development of a blood-based rapid antigen test for Ebola and Marburg viruses. The test, if it proves effective, could help boost testing capacity and national preparedness for outbreaks of pathogens with pandemic potential like Ebola and Marburg viruses, which have caused worrying outbreaks in Africa in recent years. Specifically, the funding will support the further development, validation testing, and regulatory submissions of its VeriClear EbV MARV Rapid Antigen Test to detect and differentiate Ebola and Marburg viruses in fingerstick blood samples.   A research team presented new data at the 2025 European Society for Medical Oncology Congress in Berlin, Germany last week, showing that cancer patients who received COVID-19 mRNA vaccines within 100 days of starting immunotherapy drugs survived more often than non-vaccinated patients. These findings suggest that mRNA vaccines could help improve outcomes for cancer patients being treated with immunotherapies and even patients with treatment-resistant cancers. While these results are preliminary and need to be confirmed in an upcoming Phase 3 randomized clinical trial, scientists say they could revolutionize cancer care, perhaps even paving the way for a universal, off-the-shelf vaccine for cancer.