NEW YORK – Recent, severe cuts announced by the Trump administration in US funding to programs supporting tuberculosis testing could have a devastating effect on the rate of infections and disease resistance, experts warn.
According to a World Health Organization report, approximately 11 million people acquired a tuberculosis infection in 2023. Following a rise in incidence during the COVID-19 pandemic, however, rates were slowing, and stabilizing. Rapid diagnosis of Mycobacterium tuberculosis infection is key to saving lives, but the cuts announced by the Trump administration could result in a resurgence in the treatable disease that currently kills more than 1 million people each year worldwide.
Approximately one quarter of all global support to diagnose and treat tuberculosis has come from the US, WHO has said, and over the past 20 years TB services have saved an estimated 79 million lives.
Last week, the Center for Global Development, a nonprofit economic research group, estimated that between 46 percent and 65 percent of tuberculosis support provided by the US Agency for International Development, or USAID, is on the chopping block under the new administration.
Details of the awards canceled by the US secretary of state have not been officially announced but based on leaked information, it appears that $177.9 million in support for tuberculosis programs has been explicitly cancelled, CGD noted on its website.
Along with the amount of the canceled funding, the secretive nature of what is being cut and what may be safe from being cut has spooked those following research and funding in the TB space.
"I think it’s safe to say that nothing about the canceling of these USAID contracts has been conventional," Justin Sandefur, a senior fellow at CGD, said in an email. "There does not seem to be any rational planning process, paper trail, or clear justification for specifically what is being cut," he added. "Partners are in the dark and so is the American public."
The CGD estimated that total US assistance for tuberculosis programs in 2023 was $658 million, saving approximately 306,000 lives. Saving lives is not the only benefit of TB diagnostic testing and treatment, either.
Last week in Lancet Infectious Diseases, experts wrote that shuttering the President's Emergency Plan for AIDS Relief, or PEPFAR — a program that is also supported by USAID — combined with reductions in global health research funding from the US National Institutes of Health, could result in increasing rates of drug-resistant tuberculosis.
The authors of the study, who are based at the Division of HIV, Infectious Diseases, and Global Medicine at the University of California, San Francisco, also cited an internal memorandum by a former USAID administrator suggesting tuberculosis cases could increase between 28 percent and 32 percent next year, should the current funding pause continue.
Diagnostics support
The NIH was the top funder of tuberculosis research in 2023, contributing $412 million, or 54 percent of all public spending, according to the Treatment Action Group, a nonprofit HIV/AIDS advocacy group.
An estimated $.12 of every dollar spent by NIH went to TB diagnostics research, TAG wrote in a report on tuberculosis funding trends published in December 2024.
Meanwhile, USAID was the second-largest public funder of TB research in 2023, investing $41 million that year, with $.15 of every dollar going to diagnostics research.
Among programs explicitly listed as cut was a project led by Johns Hopkins University called the Supporting, Mobilizing, and Accelerating Research for Tuberculosis Elimination, or SMART4TB. The program accounted for $15 million, or 36 percent, of USAID's 2023 spending.
Among other work, SMART4TB was evaluating the use of tongue swabs as an alternative to sputum samples for molecular testing of children, adults living with HIV, and children living with HIV. More than 96 percent of childhood TB deaths are due to missed diagnoses, and "[b]etter tools for diagnosis at the point of care means a faster start to treatment, which is vital to ending these senseless TB deaths in children," an investigator on the project, Nilesh Bhatt, said in a statement last year.
Any financial, political, or operational disruptions to TB testing and care can cause death rates to rise, WHO has said, pointing to an estimated 700,000 excess TB deaths during the COVID-19 pandemic primarily attributed to service interruptions.
Earlier this month, WHO reported that funding cuts had already severely impacted TB diagnosis. "Laboratory services are severely disrupted, with sample transportation, procurement delays, and shortages of essential consumables halting diagnostic efforts," the global health agency wrote on March 5.
TB diagnostics
The WHO has guided for the use of nucleic acid amplification testing to detect tuberculosis, and recently endorsed next-generation sequencing as an alternative to phenotypic drug-resistance testing. In December, the agency granted prequalification status to the first TB test — the Xpert MTB/RIF Ultra from Danaher subsidiary Cepheid.
Other developers of lab-based and point-of-care TB tests globally have included Abbott, Hologic, Molbio Diagnostics, Roche, Hain Lifescience, and Fujifilm. In its recent annual report on the TB diagnostics pipeline, TAG listed 36 molecular diagnostic tests for TB in development or commercially available globally.
The group also highlighted point-of-care platforms with the added value of detecting other diseases in addition to tuberculosis, including the Afinion from Abbott and Co-Diagnostics' PCR Pro, as well as systems from Coyote Bioscience, LumiraDx, whose point-of-care testing business was acquired by Roche, Nuclein, QuantuMDx, and SD Biosensor.
Rapid tests using novel approaches, like CRISPR testing of blood, tongue swabs, and host-response approaches, are also in development. Meantime, BioMérieux signed an exclusive worldwide distribution agreement with Oxford Nanopore Technologies for the AmPore-TB research-use-only M. tuberculosis assay in 2024, with a worldwide launch of the research-use product targeted for this year.
Meanwhile, detecting latent infections is also considered a critical piece to TB elimination, and Qiagen is a major manufacturer of blood-based interferon-gamma release assays, or IGRA tests. The firm said last year that it had already converted 40 percent of the latent TB testing space from skin tests to blood tests, and it is aiming to convert the remainder with a dedicated sales force and customer education programs.
Sales of Qiagen's QuantiFeron latent tuberculosis test grew 11 percent in 2024 to $454 million from $408 million, the firm recently reported. Other IGRA assays listed in the TAG report include ones from BioMérieux, SD Biosensor, and Boditech, while Oxford Immunotec, now part of Revvity, offers an IGRA blood test called T-Spot.
Although most TB efforts are focused on low- and middle-income countries, rates of tuberculosis infection in the US rose to a 15-year high last year, according to a provisional report by the US Centers for Disease Control and Prevention. There were a total of 10,347 US cases diagnosed in 2024, up from 9,633 in 2023. A year-long outbreak in Kansas has so far resulted in the diagnosis of 79 latent infections and 67 active cases and is currently ongoing.