More than 10 million people each year fall ill with tuberculosis (TB), a highly infectious airborne disease that caused approximately 1.5 million deaths in 2020. An estimated four million people with TB – two out of every five – go undiagnosed.
Efforts to reduce the TB burden are greatly hampered by the large number of people who never receive a diagnosis and therefore do not access treatment. For those who do receive a positive diagnosis, the process can be lengthy and sometimes means patients do not start on the correct treatment from the outset, which can lead to drug resistance.
Sputum smear microscopy – a TB testing method that analyses a sample of sputum, or phlegm, under a microscope – remains the primary method of testing in health centers in low- and middle-income countries where TB is most prevalent. While this method is inexpensive and technologically simple, it is limited by low sensitivity, especially in the presence of HIV-coinfection. Additionally, it requires patients to make multiple visits to health centers and is largely ineffective in diagnosing children or people in advanced stages of disease who have difficulty producing sputum. This contributes to a significant gap in care for the youngest and most vulnerable to illness.
The World Health Organization (WHO) recommends using newer, more sensitive molecular diagnostic platforms and alternative sample types to improve TB case detection but high costs, complexity, and the infrastructure required for molecular diagnostics pose considerable challenges to updating testing practices and have kept them largely out of reach at facilities where people first seek care.
With US$30 million invested, Unitaid and its partners will accelerate the introduction of new diagnostic technologies, evaluate alternative sampling approaches, and develop and evaluate combination approaches to TB diagnosis. Implemented by the Foundation for Innovative New Diagnostics (FIND) and the Liverpool School of Tropical Medicine (LSTM), the two complementary initiatives aim to improve screening and increase access to testing in lower levels of the health system.
“One person with active TB can infect between 5 and 15 others in a single year. Inadequate diagnostic capacity remains the greatest barrier to treatment and prevention, without which, 45% of otherwise healthy individuals with TB disease die,” said Dr Philippe Duneton, Executive Director of Unitaid. “With this new investment, Unitaid hopes to address this inexcusable gap in TB screening and diagnosis that leaves more than 4 million people each year without access to care for a preventable, treatable, and curable disease.”
Dr Peter MacPherson of the Liverpool School of Tropical Medicine, and Principal Investigator of the START 4-ALL Project said: “For too long, we have lagged behind targets to provide accurate, affordable, and equitable diagnosis for TB where it is most needed. The START 4-ALL Project will investigate how we can combine existing and new TB diagnostics together in combinations that are tailored to the needs of people at risk of TB. Our efforts will be focused around the community and primary care, recognizing that people with TB frequently experience multiple missed opportunities for diagnosis, which result in catastrophic health-seeking costs. By developing and evaluating combinations of TB tests that are suitable for near-patient use in these settings, we will ensure that we find solutions to provide the most accurate, feasible, acceptable, and cost-effective solutions to expand coverage to community and primary care settings and provide same-day test results”
The programs will focus efforts in nine countries – Cameroon, Bangladesh, Brazil, India, Kenya, Malawi, Nigeria, South Africa, and Vietnam – which together accounted for approximately 40% of the global TB burden and undiagnosed populations in 2020.
The new commitment builds on Unitaid’s more than a quarter of a billion dollars currently invested advance efforts against TB, including tackling drug-resistance, developing child-friendly medicine formulations, and accelerating the introduction of improved TB preventive treatment.
START 4-ALL, implemented by LSTM, will develop, and evaluate combination approaches to diagnostic screening and testing to determine the most accurate, feasible, acceptable, and cost-effective solutions to expand coverage to community and primary care settings and provide same-day test results receiving in the health center where patients first seek care.
START 4-ALL will initially focus on improving the use of existing diagnostic technologies through optimized combinations of existing tools, the project will incorporate new products expected to come to market through DriveDx4TB.
START 4-ALL will be implemented in Bangladesh, Brazil, Cameroon, Kenya, Malawi, Nigeria, and Vietnam.