Geneva – 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 FIND, the global alliance for diagnostics 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 aims 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.”
“TB is one of the deadliest infectious diseases in the world – second only to COVID-19 in recent years – yet we can test for it, treat it, and cure it,” said Bill Rodriguez, CEO of FIND. “Millions of people die from TB simply because they cannot get a diagnosis. Compounding the problem, COVID has made people hesitant to visit a health facility, leaving TB to spread unchecked faster than ever across households and communities. Providing better tests that can help communities test for TB locally, stop its spread, and ensure people can access treatment is the highest priority to tackle the TB burden. This investment from Unitaid will enable us to work with developers and communities to bridge the TB diagnosis gap so that lives can be saved.”
“For too long, we have lagged behind targets to provide accurate, affordable, and equitable diagnosis for TB where it is most needed,” said Dr Peter MacPherson, Principal Investigator of LSTM’s START 4-ALL Project. “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 quarter of a billion dollar investment to advance efforts against TB, including tackling drug-resistance, developing child-friendly medicine formulations, and accelerating the introduction of improved TB preventive treatment.
Projects links:
NOTES FOR EDITORS
DriveDx4TB (Drive Diagnostics for TB), implemented by FIND, aims to accelerate the introduction of new TB diagnostics that can address barriers to access and improve case detection at primary healthcare and community levels.
The project will generate evidence to inform policy recommendations for three technology classes that have advanced significantly as a result of investments made in testing for COVID-19. These include: third-generation lipoaribomannan (LAM) tests, which can identify TB using urine samples with a rapid test format; point-of-care (POC) molecular diagnostics designed to bring the accuracy of gold-standard laboratory tests into community settings; and near-POC molecular tests, which bridge the gap between laboratory and community health services. New sampling approaches for molecular diagnosis are also being explored, such as cheek swabs.
It will be implemented in South Africa, India, Indonesia and Kenya.
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.
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