A mobile phone, an artificial intelligence (AI) algorithm and a deadly but curable pathology. These are the elements of the challenge of Spotlab, a start-up from the Polytechnic University of Madrid, which aspires to issue precise diagnoses of visceral leishmaniasis in real time, one of the most neglected tropical diseases in the world. A new tool turns a normal microscope into a smart one to digitize the images and thus contribute to the development of the algorithm. It is just one of the many activities of this European and African consortium, led by the Neglected Diseases Initiative (DNDi), which aims to revolutionize diagnostic methods through AI and develop the first available oral treatment against ailment, two measures that move towards a possible cure.
Also known as kala azar (black fever in Hindi), visceral leishmaniasis causes between 20,000 and 40,000 deaths each year, more than half a million people infected and is, after malaria, the second deadliest parasitic infection in Africa. Transmitted through the bite of the sand fly, it is directly linked to poor housing conditions, malnutrition, population displacements, and environmental and climatic changes. The World Health Organization (WHO) estimates that between 50,000 and 90,000 new cases of visceral leishmaniasis, the most serious form of the disease (there are also cutaneous or mucocutaneous cases), occur annually worldwide, of which only to the WHO between 25% and 45%.
Faced with this problem, VL-INNO arises, a project of the Cooperation of Europe and Developing Countries on Clinical Trials (EDCTP, in English) that aims to improve current diagnostic tests through the application of AI and ensure the quality of treatment. with the creation of the first oral drug. In a disease like kala azar, which if untreated is fatal in 95% of cases and whose current therapy is old and entails costs and adverse effects in patients, access to early diagnosis and treatment are essential, since “It shortens the transmission of the parasite and, therefore, limits the spread of the disease,” explains Koert Ritmeijer, a Kala Azar specialist from Doctors Without Borders, a leading organization that together with DNDi found a new treatment regimen for patients with co-infection. infected with HIV.
The East African region is the second largest focus of this disease globally, after India. As the main researcher of the project, Eleni Ayele, explains in a telephone interview from the University of Gondar, in Ethiopia, “the available rapid diagnostic tests, called rk39, have low sensitivity in African patients, which leads to their being “they lose cases as patients do not receive treatment.” The reasons? Inadequate sampling and staining of spleen or bone marrow aspirate, little laboratory experience, use of old and low-resolution microscopes, and need for relatively high parasitemia (assess infection intensity by measuring the presence of parasites in blood) to be detected, quotes the expert. Following the WHO roadmap, which recommends the creation of a more sensitive rapid diagnostic test to improve the treatment of kala azar in East Africa, the work of this consortium may represent a breakthrough in the global fight against the disease.
Universalize the diagnosis
Elena Dacal, a parasitologist and coordinator of Spotlab’s global health projects, explains to El País how Adaptaspot, the new tool they are developing, works: “The system aligns the mobile camera with the microscope using a part made with a 3D printer, in such a way that the sample is seen through the smartphone screen.” Then, she adds, “the images obtained with the mobile phone are uploaded to the platform through an application, where the algorithms are trained to be able to recognize and quantify the leishmaniasis parasites.” When it begins to be applied, the samples will be stored remotely and permanently on the platform so that the experts from all over the world involved in the project can access them and see if they have been collected and processed correctly, without the need for a specialist to evaluate them at the place where they are collected.
“Traditionally, quality checks were done by a microscopy expert on site. The new AI algorithms will ensure that the sample is transmitted in real time: neither the smartphone nor the type of microscope nor the expert are going to influence it”, explains Isra Cruz, director of the Department of International Health at the National School of Health of the Institute of Salud Carlos III (ISCIII), another of the organizations involved in this project. In other words, and as expressed by those interviewed for this report: the final objective is to universalize the diagnosis.
Developed in Spain, the algorithm is being trained with samples collected in Ethiopia. In a telephone interview, Arega Yeshanew, the activities coordinator of the Leishmaniasis Research and Treatment Center (LRTC), explains from the Ethiopian laboratory how these technologies can contribute to curing the disease: “When an image of the parasite is correctly collected and gets on the platform, we will be able to solve the diagnostic problem and we will have a better chance of treating patients because we will not lose them. “Sometimes we give negative results when they are positive: these technologies will avoid those failures.”
Despite the fact that more than a century has passed since the Paraguayan doctor Luis Enrique Migone diagnosed the first case of visceral leishmaniasis in humans in 1911, the disease continues to raise questions to which experts have not yet found an answer: “ We do not know why the same treatment is not effective for African patients when it works in Asia. It is probably multifactorial and is related to the genetics of the individual and to the parasite itself”, responds Alexandra Solomos, DNDi’s main clinical project manager. In India, the current treatment consists of a single injection of the antifungal AmBisome, which is 95% effective. However, it does not work in East Africa, where very long, painful and potentially toxic treatments are still applied to the patient.
The solution, according to Solomos, would come with a more accessible treatment: a pill. And that is precisely what the consortium is dedicating most of its efforts to: “We have started a collaboration with the pharmaceutical company Novartis to carry out the first clinical trial with an oral treatment for the disease: a pill that will improve efficacy, but also the safety of the treatment,” he explains. But he warns that it is not only about that: “The success of the fight against the disease in regions such as Southeast Asia comes from political will and the implementation of programs for the elimination of kalaaza,” something that does not happen in Africa. The results obtained from the application of this program in Southeast Asia, published by the WHO, demonstrate that it is a combatable disease: in 2018, the number of cases was reduced from 50,000 to 5,000.
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