NEW YORK — Unitaid on Tuesday announced two initiatives, funded with $30 million from the organization, for developing same-day assays for tuberculosis and giving more people access to testing for the underdiagnosed infectious disease.
Specifically, Unitaid is partnering with FIND and the Liverpool School of Tropical Medicine (LSTM) to accelerate the introduction of new diagnostic technologies, evaluate alternative sample collection methods, and develop and test combination approaches to TB diagnosis.
FIND, the global alliance for diagnostics, said that its partnership with Unitaid includes $15.9 million in grants toward TB diagnostics development. Its four-year Drive Diagnostics for Tuberculosis (DriveDx4TB) project includes work to gather evidence on diagnostics technologies that advanced during the COVID-19 pandemic.
LSTM is implementing START 4-ALL, a project that will initially focus on improving the use of existing diagnostic technologies and later incorporate new products coming to market through DriveDx4TB.
Peter MacPherson, principal investigator for the project, said in a statement that the effort will include investigating how to combine existing and new technologies to tailor TB diagnostics to the needs of people at elevated risk. The project leaders will focus on community and primary care, where missed opportunities for diagnosis often lead to catastrophic health-seeking costs, he added.
"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," he said.
TB killed about 1.5 million people in 2020 and sickened an estimated 10 million, and about 40 percent of infections go undiagnosed. Unitaid said health centers in low- and middle-income countries primarily rely on sputum smear microscopy, which is an inexpensive and simple technology that is limited by low sensitivity and a requirement that patients visit health centers multiple times. It also is ineffective in children and people who have advanced TB and have difficulty producing sputum.
The high costs, complexity, and infrastructure requirements of molecular diagnostics "pose considerable challenges to updating testing practices and have kept them largely out of reach at facilities where people first seek care," Unitaid said.
FIND CEO Bill Rodriguez said that millions of people die from TB because they cannot get a diagnosis, and TB is now spreading faster across households and communities because COVID-19 has made more people hesitant to visit health facilities.
"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," Rodriguez said. "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."
The collaborators plan to focus their work on nine countries that accounted for about 40 percent of the world's TB burden in 2020: Cameroon, Bangladesh, Brazil, India, Kenya, Malawi, Nigeria, South Africa, and Vietnam.
FIND said it will conduct in-country manufacturer-independent clinical accuracy studies, cost effectiveness analyses, and usability studies, the results of which would be submitted to the World Health Organization Global Tuberculosis Program and Expert Review Panel for Diagnostics. The organization is issuing requests for proposals for third-generation lipoarabinomannan tests, point-of-care molecular diagnostics, and near-point-of-care molecular diagnostics.