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Tuberculosis (TB) is the leading cause of death from an infectious disease worldwide, claiming an estimated 1.25 million lives in 2023. Of the 10.84 million people estimated to have developed TB that year, only 8.16 million were diagnosed and reported — leaving 2.7 million people missing: undiagnosed, unreported, untreated, and not cured.1 This persistent diagnostic gap highlights the shortcomings of existing tools and the urgent need for better ones. Decades of reliance on smear microscopy and culture, inadequate access to World Health Organization (WHO)–recommended rapid diagnostics tests (WRD), and the high price and technical complexity of modern molecular tests have left millions without timely diagnosis.2 In 2023 alone, currently available rapid diagnostic tests failed to reach 4.3 million people with TB (a figure that does not account for individuals with TB diagnosed or missed in the private sector).3 Across the diagnostic pathway, from screening to treatment monitoring, losses occur at multiple steps, preventing people from accessing curative treatment when they need it most. Recent progress in the pipeline offers hope. A new class of near point-of-care (nPOC) TB tests, undergoing WHO review in November 2025, brings a focus on decentralization, faster turnaround times, and the use of nonsputum samples. By enabling testing closer to the point of care, simplifying sample collection by using oral swabs, and delivering rapid results (within 30 minutes), these nPOC tests aim to increase access to testing, reduce losses to follow-up, and accelerate treatment initiation — key steps in closing the TB diagnostic gap. The 2025 TB diagnostics pipeline is broad and diverse, with multiple tools now in late-stage development approaching policy and regulatory review. Yet innovation alone will not close the diagnostic gap. To translate scientific progress into lives saved, these new tools must be taken up by governments through the exercise of strong political will, well-designed programs, sustained funding, and deliberate strategies for equitable access. Several things must happen at once: replacement of outdated technologies accompanied by rapid scale-up of proven tests enabled by commitments to affordability and integration into health systems. This year’s TB Diagnostics Pipeline Report adopts a stance of cautious optimism about the potential of the innovations emerging in the pipeline, particularly tools in the nPOC class, while emphasizing the urgent need for decisive investment, accelerated uptake, and dedicated efforts to guarantee access. Without these, millions of people currently missed by TB diagnosis will remain beyond even the reach of new tools.