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European UTI-Diag Project Aims to Deliver POC Testing for UTIs in Sub-Saharan Africa

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NEW YORK – In March, a new EU-funded project will commence that aims to deliver a series of new tests and tools for diagnosing urinary tract infections in low- and medium-income countries, especially in sub-Saharan Africa.

The €4.5 million ($4.7 million) effort is called UTI-Diag and is being led by researchers from the Karolinska Institutet in Sweden. It also involves a diverse crew of partners, including companies with expertise in developing lateral flow tests and point-of-care devices.

UTI-Diag will officially start on March 1 and will run through the end of August 2028. Intended deliverables include a lateral flow test for detecting biomarkers in urine for the purpose of triage and a point-of-care instrument to help hospitals and clinics guide prescription of antibiotics to patients.

The envisioned "toolbox" will also include self-sampling cards for field use and a digital health platform for clinical decision support. The investigators will also trial their tests in the field with the help of African partners, with the goal of readying the tests for regulatory clearance by the end of the project. UTI-Diag will also be able to transfer manufacturing of the tests to local partners in Africa by 2028.

Giulia Gaudenzi, an assistant professor in the Department of Global Public Health at Karolinska Institute, is a co-principal investigator on the project. She said that the new project aligns with Karolinska's commitment to "reducing health disparities, strengthening healthcare systems, and supporting sustainable medical innovations, particularly in low-resource settings."

Gaudenzi's work in particular is focused on advancing point-of-care diagnostics for low-resource settings. Her co-PI is Tobias Alfvén, a professor of global child health at the institute. In addition to coordinating UTI-Diag, their team at Karolinska will be involved in clinically validating the resulting tests, ensuring their regulatory compliance, and carrying out a cost-effectiveness analysis. This will ensure the new tools "improve early detection, antibiotic stewardship, and healthcare access," Gaudenzi said. The team will also enroll Ph.D. students as part of the project in order to further build capacity in global health and diagnostics, she noted.

One UTI-Diag participant is Global Access Diagnostics, or GADx, which will contribute its UTI lateral flow self-test for rapid screening. The UK company has 20 years of expertise in lateral flow test design and manufacture and offers a variety of products for infectious disease testing. GADx will also be responsible for manufacturing the tests, including provision of the necessary antibodies, gold nanoparticles, membranes, and plastic housing, Gaudenzi noted.

Emily Adams, chief global health officer at GADx, said that the company already has a prototype of its UTI self-test available. For UTI-Diag, GADx will provide this test, which consists of a dipstick that can be made available in bottles of dozens of strips, making it ideal for use in low- and medium-income settings.

"These will be used by healthcare workers as a professional test," said Adams. "This would be something that people attending inpatient and outpatient clinics would get access to."

The product tests for the presence of enzymes secreted by active neutrophils that are present in urine and highly indicative of urinary tract infections. Quicker UTI diagnoses will enable healthcare workers to put patients on the right therapies. "It can be difficult to recognize UTIs in pregnant women and postpartum women as there is often general pain and urinary pain," said Adams. She added that patients in nursing homes can have dementia-like symptoms that are actually caused by UTIs.

Because of this, Adams said the development of such a test is "important."

As GADx refines the dipstick self-test for UTI-Diag, it is also proceeding with the existing wick-based plastic-handle version, UtriPlex, for which it has already accrued data on UK test subjects within a healthcare setting. This test is in the same format as other lateral flow tests. The company is also seeking partners in the US to take part in clinical trials of UtriPlex, she said.

By taking part in UTI-Diag, the company will be able to see how its markers perform in African populations. "Some of our data comes from London, which has a very diverse population, but we are excited to see if the biomarkers perform as strongly in African settings," said Adams.

Aidian, an Espoo, Finland-based in vitro diagnostics company, is responsible for developing the point-of-care instrument for UTI-Diag.

The company sells a point-of-care platform called QuikRead Go, which the company says is CE-IVDR compliant. The envisioned UTI-Diag device will include pathogen detection capabilities, relying on isothermal nucleic acid amplification, and will also measure host-response biomarkers, which will aid in monitoring infection severity and kidney function and help with the selection of antibiotics for patients.

Cumbria University in the UK and Albert-Ludwigs-Universität Freiburg in Germany are also working on the point-of-care instrument as well as its clinical validation, Gaudenzi said.

Gaudenzi said that the UTI-Diag point-of-care instrument is also currently in prototype form and "will require further clinical validation before regulatory approval."

Other partners involved in UTI-Diag include Capitainer, a Swedish company that will provide biofluid sampling cards, as well as Aviro Health, a South African social enterprise that will create the digital health platform for UTI-Diag.

Gaudenzi said the digital health platform would connect the results of the UTI self-test and UTI-Diag point-of-care tests so that they could be used seamlessly in clinical workflows. The digital health platform will offer decision support tools, training modules, and automated patient management, she said. It will also support remote monitoring, real-time communication, and secure data collection and will be built on Amazon Web Services.

According to Adams, while the scope of the trials for the toolbox has not yet been decided on, in all likelihood, both the lateral flow test and the POC instrument will be trialed in cohorts of about 600 people. This will be achieved with partners at the Institut Pasteur de Dakar in Senegal and the Centre Pasteur of Cameroon. These partners will evaluate the performance of the new tests against conventional diagnostic methods.

A final partner in the mix is Market Access Africa, an African healthcare consulting firm that will advise UTI-Diag on market access, regulatory strategy, and commercialization. Gaudenzi said that UTI-Diag very much sees a market launch of the new tests sometime in 2028. It will also work toward regulatory clearance, including in Europe, to facilitate that market entry.

Initial implementation is planned in Senegal and Cameroon, with potential expansion into Ethiopia, Uganda, Ghana, and Nigeria. A potential manufacturing partner could be Diatropix, a diagnostic manufacturing site that announced its expansion last month in Mbao, Senegal. GADx is a partner in Diatropix and has a technology transfer agreement in place with the facility.