After struggling for decades with either suboptimal (e.g. sputum microscopy), slow (e.g. cultures), or expensive (e.g. GeneXpert) molecular tools, the field of tuberculosis (TB) is finally entering a new era. An era when countries with a high burden of TB now have access to the world’s most affordable molecular diagnostic, priced at US $2.6 per test, that can be used in primary care settings, and can be done with tongue swabs, when people are unable to provide sputum samples.

This breakthrough will hopefully allow high TB burden countries to finally replace smear microscopy with molecular testing, close the massive gap in TB detection, and greatly expand access to testing. In 2024, 2.4 million people were not diagnosed with the disease, or not officially reported to national authorities, according to the World Health Organization (WHO). In the same year, a WHO-recommended rapid molecular test was used as the initial diagnostic test for only about half of the 8.3 million people newly diagnosed with TB. Many countries are still using the antiquated smear microscopy test with low sensitivity, in part because molecular testing has been unaffordable until now.

But now, countries have a viable path to fulfilling WHO’s standard for TB diagnosis, which requires a rapid molecular test to be used for all people with presumptive tuberculosis.

WHO leads with strong guidance

In February this year, the World Health Organization (WHO) recommended , for the first time an entire class of testing that did not exist until recently. This class is called near point-of-care nucleic acid amplification tests (NPOC-NAATs). WHO recommended that NPOC NAATS can be used (1) on sputum samples as an initial diagnostic test for adults and adolescents with symptoms or screen-positive of pulmonary TB, replacing smear microscopy, and (2) on tongue swabs as an alternative when sputum cannot be obtained. According to WHO, NPOC-NAATs can be done in basic peripheral laboratories, health clinics, mobile units, or community sites that do not have laboratories. They can be performed by health care workers with basic technical skills.

In April this year, WHO rapidly followed up with a helpful toolkit which includes training content, job aids, and other practical tools for implementing these tests.

To get to this point of WHO approval, test manufacturers, funders, test evaluators, and regulators played a critical role. Jerry Cangelosi , a professor emiritus at the University of Washington, Seattle, was among those who played a key role in the early development of a TB test using oral swabs. “A lot of innovation went into making this possible and swab testing was only one of them,” he said. “The key innovation is to view TB testing not only as a patient care tool, but also as a tool for public health and human rights. Historically, TB pathogen transmission has been far more commonplace than case detection, and humanity could never get caught up. The only solution is to stand that on its head, and we’re now much closer to realizing that dream. It is an exciting time to be in TB diagnostics," he added.

Test becomes more afforable

Currently, the only WHO-endorsed technology in this new NPOC class is the MTB Nucleic Acid Test Card with the MiniDock Ultra device by Pluslife Biotech (Guangzhou, China). This technology received funding support from the Gates Foundation and other donors, which included global access and volume-based pricing as a key condition.

Launched initially at a cost of USD 3.60 per test, this test price is now US $2.60, making it the most affordable WHO-endorsed molecular test for TB. Actual costs when they reach countries will, of course, include shipping and duties. The MiniDock Ultra device available for $155. In field settings, they can be run with simple power banks, when continuous electricity is a challenge.

Countries begin rollout, even amidst aid cuts

Within months of WHO policy, despite steep cuts in international aid by the United States, United Kingdom, as well as other G7 nations, more than 15 high TB burden countries are already rolling out the MiniDock test.

Thirteen countries are rolling out these tests as part of an Early Adopter initiative driven by the Global Fund, supported by the Children’s Investment Fund Foundation (CIFF). This initiative will see nearly 3 million tests done in Bangladesh, Benin, Cameroon, Ethiopia, Indonesia, Kenya, Nigeria, Peru, the Philippines, South Africa, Uganda, Viet Nam and Zambia.

The reduced price comes exactly at a time when countries are struggling with the impact of aid cuts. Zimbabwe is one among the early adopter countries impacted by aid cuts. “The reduced PlusLife test price of US$2.60 is a significant step towards making high-quality molecular TB testing more accessible and affordable,” said Fungai Kavenga , Deputy Director- TB Prevention and Control, in the Ministry of Health. “It strengthens our business case for scaling up near point-of-care testing, enabling us to expand access to rapid diagnosis in underserved communities while making more efficient use of limited resources,” he explained.

“We couldn’t be more excited,” exclaimed Norbert Ndjeka , Manager of South Africa’s National TB Program. “This price reduction will go a long way in increasing access to TB testing in high burden areas like South Africa and Africa in general,” he added. South Africa too has been impacted by aid cuts, especially with its HIV treatment program.

In addition, the TB REACH program by the Stop TB Partnership is helping many countries try out the NPOC technology, using various innovative strategies for implementation. Supported by Global Affairs Canada, the Gates Foundation, and UK FCDO, TB REACH Wave 11 Plus is investing US$ 2.7 million across 18 projects in 12 countries, with about 150,000 tests expected to done in 2026.

NGOs are also involved in the rollout of NPOC testing. Janna Health Foundation is an NGO that works in communities impacted by diseases such as TB and HIV. They are deploying NPOC testing in nomadic communities, with TB REACH support. "The NPOC cost reduction will enable Janna Health Foundation overcome the current shortages in supplies and improve testing coverage among key, vulnerable and underserved communities in Nigeria,” said Stephen John, Secretary of the Foundation.

Dopasi Foundation is an NGO based in Pakistan. With support from TB REACH, they are embedding NPOC into an integrated TB and lung health service delivery model, which takes testing closer to where people live and work. “The real breakthrough is not only a $2.60 molecular TB test - it is what that price can unlock. For high-burden countries like Pakistan, it creates a pathway to move accurate diagnosis out of centralized laboratories and into primary care and communities, bringing testing within reach of people who have historically been left behind,” said Kinz ul Eman , CEO, Dopasi Foundation.

A growing call to replace smear microscopy and expand testing

Civil society advocates have been increasingly calling for high TB burden countries to phase out smear microscopy and replace them with WHO approved rapid molecular testing for initial testing of TB. The reduction of Pluslife pricing may tip the scales further in favor of molecular testing, and help reach a larger fraction of people who need to be tested for TB.

“For the price of one Xpert cartridge, a country can now run three TB tests and reach three times as many people where they seek care, at the primary health care level,” said Tapiwa Kujinga , Diagnostics Equity Consortium ( DEC ). “With this reduced price, countries should be able to replace old-time microscopy as the initial diagnostic and double the number of tests performed,” he added.

A growing pipeline of NPOC technologies

While MiniDock by Pluslife is the first NPOC test to win WHO’s endorsement, there are several similar technologies under development or evaluation. This makes sure countries have choices for procurement. Some of the companies in this space include Huwel Lifesciences, India; Molbio Diagnostics, India; UStar Biotechnologies, China; Coyote Bioscience, China; and Co-Dx , USA. While the current MiniDock TB test cannot perform drug-resistance testing, future versions of MiniDock and products by other companies will likely make such drug-resistance testing feasible. For now, drug-resistance testing will require existing platforms such as GeneXpert, line probe assays, and liquid cultures.

As I highlighted elsewhere , Global South companies are now leading the TB innovation space. These innovations are more affordable, better designed for the Global South context, and are more likely to be scaled up. When combined with greater investments by Global South governments, there is hope to reverse the damage caused by aid cuts. Indonesia is an exemplar. This country is deploying NPOC testing, with an aim to reach 10,640 primary health centers in 38 provinces by 2027, with 90% of the TB budget coming from domestic sources. If other countries can follow suit, TB testing gaps will shrink.

Note: I have no financial or industry conflicts with any of the technologies or companies mentioned in this article. I serve as an advisor for several non-profits, including WHO, Partners in Health and the Gates Foundation