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US-Spanish Team Developing Lateral Flow Test for Malaria Diagnosis, Prognosis

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NEW YORK – A new European research project aims to deliver to the market a lateral flow test for diagnosing malaria in patients at the point of care, while allowing clinicians to determine the severity of their disease and whether they will require treatment.

The effort, called Malaria Diagnostic and Prognostic Testing, or Maldiprot, commenced this month and is being led by researchers at the Barcelona Institute for Global Health (ISGlobal) and Columbia University in New York. The EU has awarded the researchers €188,000 ($204,000) to support the project through September 2026, by which time they hope to have a validated prototype ready.

Amadeo Sena, a postdoctoral research scientist at Columbia University who is overseeing the project, said that while lateral flow tests exist for diagnosing malaria, making any prognosis of the disease involves parasite counting via microscopy, which is unsuitable for point-of-care use. This is more so the case in countries where malaria is endemic, such as in sub-Saharan Africa.

"Commercial tests don't provide clinicians with information on severity," said Sena. "There are places in Africa where hospitals are located far away, and so it's not easy for people to go there," he said. "We need to select the patients who really need therapy, so they can get it."

Similar to COVID-19, malaria patients run the gamut from the asymptomatic to those at risk of death. Those with uncomplicated malaria might have a fever but can be treated at home, said Sena, but some patients progress rapidly to severe malaria with elevated levels of parasites in their blood. The idea underpinning the project is to develop a test to stratify these two groups.

"We need to know if a person has uncomplicated malaria or severe malaria to reduce the impact on the healthcare system," Sena said.

According to the European Center for Disease Prevention and Control, there are about 250 million cases of malaria worldwide per year and about 600,000 deaths. Most cases of malaria occur in sub-Saharan Africa, but it also occurs in parts of Oceania, as well as in parts of Central and South America and Southeast Asia.

However, as Sena noted, migrants are bringing malaria cases to Europe in greater frequency, and given global warming and climate change, rates are increasing in Mediterranean countries, such as Italy and Spain. According to the ECDC, there were about 6,000 cases of malaria in Europe in 2022. The rise in incidence of infectious diseases in Europe, the US, and other northern countries, is not limited to malaria, and diagnostics developers are working through a variety of channels to address the threat.

"We need to address the situation in endemic countries," said Sena, "and to have these tests available in Europe, just in case."

The objective of the project is to develop a paper-based lateral flow assay that can quantitatively measure malaria biomarkers within minutes through a smartphone. The researchers are aiming to develop an assay that is sensitive enough for low parasite counts. The project builds in part on previous studies by researchers at ISGlobal that identified biomarker threshold levels in malaria patients that could be used to stratify the severity of their disease. A paper appeared last year in the journal Travel Medicine and Infectious Disease describing the new findings.

The number of markers on the test could range from angiopoietin 2 and C-reactive protein, both detailed in the study, to perhaps four more, making for a total panel of six protein markers.

Sena acknowledged that some elements of the assay exist in other contexts. While current malaria lateral flow tests rely on antibodies, the project will use targeted aptamers. This is one of the reasons that ISGlobal is collaborating with the group of Milan Stojanovic, an associate professor in the departments of medicine and biomedical engineering at Columbia, given his group's expertise in aptamer design. While aptamer-based lateral flow assays have been used in diagnostics, none have been fashioned to diagnose malaria and offer a prognosis, Sena said.

"The novelty of this work is to detect diagnostic and prognostic markers for a single platform for malaria," he said.

The final device will support the sample treatment, washing, and amplification steps using a smartphone to control the speed and direction of the sample within the paper-based device. All energy needed for running the assay will be provided by a smartphone battery, making it portable.

Sena, who also is affiliated with ISGlobal, is just getting started, acquiring reagents and designing experiments.

As the project progresses, ISGlobal will help to validate it and assess its performance, both in a travel medicine clinic in Barcelona as well as with partners in Africa. ISGlobal has research infrastructures in Sierra Leone and Mozambique, two of the most affected malaria countries.

The goal is to test the resulting assay in the field by the time the Maldiprot project ends in 2026.

After that, it's possible the test could be transferred to a company for commercialization, or a spinout might be considered to make the test more widely available to customers in target areas.

Claudio Parolo, an external associate researcher at ISGlobal, said that a spinout is likely, though he stressed the project is still in the research phase. He said the new effort is aligned with the institute's goal of improving global health from both the clinical and environmental perspectives.

Parolo, who is also a Ramon y Cajal Researcher at the University Rovira i Virgili in Tarragona, noted that the research group involved in Maldiprot is specifically involved in travel medicine and diagnosing and controlling neglected tropical diseases, such as malaria and dengue in endemic areas.

Parolo himself leads a laboratory at ISGlobal, where he is focused on the development of lateral flow assays, electrochemical aptamer-based sensors, and DNA scaffold sensors.

"The overall goal is to make a rapid diagnostic test that can be used at the point of care, such as at a travel clinic, in rural areas, and during travel, as well," Parolo said of the Maldiprot project.