Supporting the introduction of the first-ever locally manufactured UTI diagnostic tool

A breakthrough in the development of UTI-Diagnostic tools is in the horizon. Market Access Africa’s life sciences experts Pam and Tarisiro take us through the UTI-Diag journey, unpacking the factors leading to formation of the 11-partner consortium and the innovations being developed to ensure better access to fit for purpose diagnostic tools.

Market Access Africa: Please give us an overview of the UTI-Diag project and the role Market Access Africa is playing in the 11 partner consortium.

Pam: The UTI-Diag project focuses on the development of novel urinary tract infection diagnostics.  

The UTI-Diag Consortium has a number of partners and some of these partners, particularly ones from Europe, are universities and diagnostic manufacturers that have come together to develop diagnostic products to help solve the challenges around the lack of specific urinary tract infection diagnostics through lateral flow, pathogen detection, antimicrobial resistance detection, and immunochemistry diagnostics that are related to UTIs. Market Access Africa is helping the consortium to really understand the current need on the ground. One method of doing this has been conducting voice of customer assessments in five countries across Africa. Through the assessments, we have collected feedback on the patient pathways, diagnostics being used, the challenges and gaps which if improved through the diagnostics in development, could significantly advance diagnostic technologies for urinary tract infections.  

Beyond diagnostic development, we are also contributing to work around regulatory considerations and commercialization pathways, to support strategy formulation for product adoption.  

Market Access Africa: Why should urinary tract infections and the antibiotic resistance they drive be a priority for African health systems right now? 

Tarisiro: Urinary tract infections are typically diagnosed syndromically, meaning there is no actual diagnostic test that is used to diagnose a UTI. Often there is what we call a urine dipstick, which detect markers that are not necessarily specific to a UTI. In recurrent cases and in facilities where available, urine culture and AST are performed to determine the causative pathogen and antibiotic to effectively treat the infection which often takes up to 72 hours to obtain results. As a result, health practitioners prescribe broad spectrum antibiotics for treatment without a firm diagnosis, ultimately leading to antibiotic resistance. Over the years, this has become a growing challenge because we are essentially running out of antibiotics to use due to antimicrobial resistance as in the case of Sexually Transmitted Infections. But the reality still exists, despite limited access to diagnostic tools and the right antibiotics; if patients with UTIs go untreated, they are likely to develop more severe infections and complications. Prioritizing the development and distribution of essential diagnostic tools for conditions like UTIs therefore becomes imperative.

Market Access Africa: Diagnostic uncertainty in presumed self-limiting or bacterial infections can lead to unnecessary antibiotic prescribing. What innovations are being developed through the UTI-Diag Project to improve accurate and timely diagnosis?

Pam: The consortium is developing a number of products under the UTI-Diag project. The first one is the UTI Lateral Flow Test, a first line screening tool designed to improve the widely used urine dipstick. The Lateral Flow Test has specific UTI inflammatory urinary biomarkers to determine whether somebody has a urinary tract infection or not. It is expected to be more specific than the existing dipstick.  

There are also integrated near points of care instruments in development, which will serve as confirmatory tools with immunoassay tests and nucleic acid testing on one single platform. The test is designed to detect E. coli, Klebsiella pneumoniae, as well as genotypic antimicrobial resistance markers for ESBLs and carbapenemases.

The UTI- Diag project has also seen the development of a dry spot card for urine and whole blood to help test samples that are more stable because sample transportation is a challenge across Africa, being able to put samples onto a dry spot card will therefore preserve them and help improve the quality of results.  

The fourth product that is being developed is a connectivity platform that can help capture results from the lateral flow test and from the near point of care instrument, enabling integration of results into laboratory systems and health care platforms in countries.

Market Access Africa: A diagnostic can perform brilliantly in a trial and still never reach a patient. What actually stands between a validated tool and a clinic in Nigeria? How is MAA contributing to bridging that gap?

Tarisiro: Some diagnostic tools are not designed for the local context and fail to consider the infrastructure that exists. Clinical trials are often conducted in controlled environments which may not match the realities of other health facilities, including electricity and cold chain challenges, or inaccessible locations. In situations where the tools reach facilities, there is often limited consideration of the existing workflow of health practitioners resulting in poor adoption.  

A limitation we cannot run away from is cost. Despite the willingness of Ministries of Health to allocate more resources to improving access to diagnostic tools, most health budgets are already stretched thin. The tools may be effective in detecting specific pathogens, but extremely expensive to acquire, making it difficult to place the tools in public facilities.

We are bringing in the voice of customers to address these challenges through speaking to various stakeholders including health practitioners, nurses, doctors, lab staff, distributors, and researchers. By having them understand the full suite of diagnostic tools available, their insights help us to answer specific questions around utility, challenges with current diagnostics, potential barriers and drivers of adoption of new products, measures to take to ensure availability and adoption of the tools being developed through this project.  

Market Access Africa: The project points to local manufacturing and pooled procurement as routes to scale, what does this practically look like for African countries?

Pam: We currently do not have a single diagnostic or dipstick that is manufactured in Africa. Through this project, a tech transfer plan is being developed to transfer the UTI Lateral Flow Test to Institute Pasteur Dakar. This will mean local manufacturing of this diagnostic in Africa, presenting a unique opportunity for increasing manufacturing resilience and reducing import dependence. We are excited to see how this translates. Senegal adopting a technology that is homegrown has far reaching benefits for the rest of the continent, making decisions to buy products that are manufactured in Africa a reality. If we can work with organisations such as Africa CDC and their pooled procurement mechanism, this will help to improve terms of negotiation and pricing of raw materials for manufacturing and for countries to procure at better prices from manufacturers.  

What conversation is Market Access Africa driving at the International Conference on Diagnostic Innovation in Sub-Saharan Africa?
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Pam: Market Access Africa will be part of a high level panel discussion focused on scaling diagnostic innovation in Africa. Building on our experience in new product introduction across the continent, we are hopeful that we can have a conversation that catalyzes fresh thinking, through how we unlock the bottlenecks encountered when introducing new products - from navigating the regulatory landscape, supply chain challenges, laboratory capabilities, and the institutional resistance to change. There is a very simple take-away that we want to keep elevating - innovation should primarily be driven by need.  

Market Access Africa: Artificial intelligence is emerging as a powerful tool for tackling infectious diseases and addressing AMR. What innovative diagnostic approaches are you currently excited about and look forward to seeing at the upcoming conference?

Tari: It has been interesting to see the models being developed to detect pathogen genomes and quickly identify resistance genes. This has mainly been done with whole genome sequencing. While this is under development, being able to see a model like this in a very small diagnostic tool will be transformational because it means that we no longer have to wait hours to determine or identify the resistance gene. This will also mean minimising some of the more manual routine diagnostic methods being used.  

Pam: There are so many AI diagnostic tools in development that are exciting to watch because they really have potential to help with improved diagnosis and treatment, which will ultimately have a ripple effect on curbing antimicrobial resistance. I would like to spotlight the digital stethoscope being developed by AI Diagnostics which focuses on TB screening. The team are involved in a multi-country study to show the value of their product and generate the necessary data for national adoption considerations.  

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