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N7*

TMEK - the quantitative rapid diagnostic test for Malaria

Prof. Riccardo Bertacco, Politecnico di Milano; Prof. Giorgio Ferrari, Politecnico di Milano; Prof. Gianfranco B. Fiore, Politecnico di Milano; Dr Marco Giacometti, Politecnico di Milano; Dr Francesca Milesi, Politecnico di Milano; Dr Lorenzo Coppadoro, Politecnico di Milano; Dr Jonathan Barsotti, Politecnico di Milano; Dr Tommaso Pravettoni, Politecnico di Milano

Politecnico di Milano


Challenge

Malaria is a very serious and extremely widespread disease: according to the World Health Organization (WHO), in 2017 it is estimated that 219 million new cases occurred, mostly in Africa. TMek is a lab-on-chip diagnostic test, suitable for early detection of malaria, designed to answer the need of a rapid and effective screening of the population where the socio-economic conditions make the solutions currently available on the market inappropriate or ineffective.


Technology

More than 430,000 people die every year in Africa from this disease, which would be easily treated if early diagnosed. In less than 10 minutes TMek provides an accurate diagnosis of the presence of any type of plasmodium, the parasite that causes malaria, in the patient blood. TMek is a compact system, according to the "lab-on-chip" approach, consisting of a low-cost "disposable" microchip connected to an electronic reading module. It is based on the magnetic properties of infected red blood cells (RBCs) and hemozoin crystals (HC) produced by plasmodium, the malaria pathogen. A drop of blood is collected on a slide then placed in contact with the silicon chip. Infected RBCs and HCs are attracted to magnetic concentrators, while healthy RBCs sediment. The detection takes place by measuring the variation in electrical impedance at each concentrator. The tests currently available for this diagnosis are: observation of the blood drop under the microscope, PCR and Rapid Diagnostic Tests (RDT), all characterized by long execution times and the need for expert operators, not always available in the countries where the malaria is endemic.


Commercial Opportunity

The market of Tmek is that of the RDT, with more than 312 million devices sold every year, despite the known limits of this technology. The global market is estimated to be about 100 million dollars/year, due to the strong effort of the WHO to reduce the test costs in the endemic countries (0,2 -0,7 $ versus 13 $ in developed countries) (Find Report 2016). The mission of the Tmek Team is developing diagnostic technologies suitable for on-site use in endemic zones. In this spirit, the team invented the concept of “social patent”,i.e. a form of protection of the intellectual property beyond the pure economic deployment. The patent royalties will be re-invested in research and development of projects with high social impact. The business model is based on the principles of corporate ethics, with the aim of conjugating high technology, sustainable economy and social needs.


Development Status

In 2019 the first prototype of Tmek was tested on human blood at Luigi Sacco Hospital in Milan and in Camerun on 86 subjects. The results are promising: the devices proved to be capable of performing a direct and automatic quantification of the parasitaemia (Sensitivity: 100%, Specificity: > 75%, LoD: 10 par/microL for 10 minutes capture). The team is now optimizing the chip to reduce size and costs and a new trial is planned for the second semester of 2020.


Patent Situation

Two patent families are protecting the Intellectual Property Rights of Tmek:

- Granted Italian Patent, extended with patent applications in US, Europe, China, India.

- Italian Patent application, extended with the PCT application .


Further Reading

Tmek website: www.tmekdiagnostics.com/en/


 

TMEK - the quantitative rapid diagnostic test for Malaria