The revolutionary rapid diagnostic test for malaria

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What MALARIA means

Data from: World Malaria Report 2018

50%

of the world population at risk of infection

92%

of cases was in Africa Region

97%

of deaths was in Africa

219 M

cases in 2017

435.000

deaths

61%

of deaths was children under 5 years old

WHO recommends prompt parasite-based diagnosis in all patients suspected of malaria before treatment is administered. Malaria rapid diagnostic tests have the potential to greatly improve the quality of management of malaria infections, especially in remote areas with limited access to good quality microscopy services.

Rapid Diagnostic Test market size

Data from: World Malaria Report 2017


global market
312 M RDT sold per year

 concept

Malaria disease is caused by the Plasmodium parasite, which attacks red blood cells. During the intra-erythrocytic development Plasmodium feeds on hemoglobin, degrading it into hemozoin nanocrystals. Being paramagnetic, these crystals allow for the magnetic separation of infected red blood cells from healthy ones.
The diagnostic test TMek exploits this property to quantify infected red blood cells:

1. a small drop of blood is placed on a glass slide

2. a microchip with some micron-sized magnetic concentrators and electrodes, is placed on top of the glass slide, in the magnetic field produced by an external magnet

3. healthy RBC and other corpuscles sediment while i-RBC are captured on the surface of concentrators, where the electrodes allows for their quantification

4. the signal is displayed on a notebook or smartphone connected to the diagnostic apparatus.

TIME-SAVING

QUANTITATIVE

METHOD

PANPLASMODIC

SENSITIVITY

SINGLE DROPLET

ON-CHIP

NO QUALIFIDED

PERSONNEL

Competiton

Need of a compact, low-cost and easy to use diagnostic system, which allows a rapid detection, with the same sensitivity of the Gold Standard

World Healt Organisation

State of the art of diagnostic tests 

GS: It consists of the direct microscopic parasite investigation performed both on a thick and on a thin blood film stained on a glass slide. The evaluation is performed through the count of the number of infected RBCs over different fields of view and the result is expressed with respect to the total number of RBCs evaluated (parasitaemia%). The limit of detection (LoD) ranges from 4 to 20 parasites/uL, but the operational time required for the analysis is around 30 to 60 minutes. Moreover the accuracy is user dependent.

RDT: Antigen-detecting RDT technology it is considered to be a significative alternative to the gold standard. The solution proposed by the RDT technology is cheap and easy to use. The test is fast compared to the gold standard, requiring only 20 minutes, and it can reach a LoD that is around 200 parasites/uL. Critical aspects of RDTs are the presence of a sizable number of false positive and negative results, as well as the inability to quantify the parasitaemia, leading to a non quantitative diagnostic test.

PCR: is based on the detection of specific nucleic acid sequences. It is an enzymatic assay which amplifies a specific segment of a DNA template by creating thousands of copies of that particular sequence. It presents the highest sensitivity and specificity that both reaches 100% for parasitaemia levels of few parasites/uL (0,0001%) and, in addition, it is able to detect all kind of plasmodium species. High costs, long operation time, and the fact of being a qualitative test in the version suitable for on field application, are the critical aspects of this technology.

Among other advantages, TMek is faster than any diagnostic test currently on the market (it takes just 7 minutes) and offers the unique feature of allowing for the automatic quantification of the parasitaemia.

MISSION

Our mission is developing diagnostic technologies suitable for on-site use in endemic zones, like the rapid diagnostic test TMek for malaria. The initial project “Tid Mekii” (from the name of malaria in Camerun), originates from the social program “Polisocial awards” of Politecnico di Milano. In this spirit, we invented the concept of “social patent”, i.e. a form of protection of the intellectual property against a pure economic deployment.
Our business model is based on the principles of corporate ethics, with the aim of conjugating high technology, sustainable economy and social needs.

SOCIAL PATENT

The nature of the Polisocial Awards grant which made possible the research on TMek, forced us to think about an unusual kind of protection of the intellectual property: the “social patent”. The scope was not protecting our intellectual properties to beneficiate from possible revenues or other economic initiatives. The idea was to protect the invention against a pure economic deployment. Malaria is a serious medical and social problem; our invention couldn’t become just a way of transforming it in a business.
For this reason, in agreement with the TTO of Politecnico di Milano, we signed an internal document preliminary to the patent application where the inventors:

1. give up all possible revenues from the exploitation of the IP, while declaring their interest in continuing the development of the diagnostic test;

2. request that Politecnico di Milano adopt a no-profit exploitation strategy, compatible with the principles of responsible, sustainable and fair development, as well as attentive to local and global social needs. This was the ideation of the “Social Patent”.

Where we are

S2P competition 2018
WINNERS

Disruptive Innovation Award

ProtoC

Prototype under validation at Sacco Hospital and in Cameroon

Clinical validation

St Luc Hospital of Mbalmayo – Cameroon


features after the first validation

  • Direct and automatic quantification of the parasitaemia
  • Quantification of circulating malaria pigment
  • Panplasmodic test
  • Suitable for post treatment monitoring of illness evolution
  • Specimen: 7 microL of whole blood from a prick test
  • Test operating time: 7 minutes
  • Storage conditions: -20°C – 50°C (to be refined)
  • Sensitivity: 100% (93.3-100) (venous sampling) – 100% (63.0-100) (capillary sampling)
  • Specificity: 69% (49.2-84.7) (venous sampling) – 100% (capillary sampling)
  • LOD: 10 parasites / microL (0.0002% parasitaemia)

Development plan/1

Who we are

The dreamers

Riccardo Bertacco

Riccardo Bertacco

Coordinator

Full Professor
Dept. of Physics – Polifab

Giorgio Ferrari

Giorgio Ferrari

Development of the integrated electronics

Researcher– Electronic Eng.

Gianfranco Beniamino Fiore

Gianfranco Beniamino Fiore

Hematic treatments

Associate Professor
Biomedical Eng.

…and who makes it happen

Marco Giacometti

Marco Giacometti

Electronic realization
Test optimization

PhD Candidate in Electronic Eng.

Francesca Milesi

Francesca Milesi

Chip production
Test optimization

PhD Candidate in Physics Eng.

Lorenzo Coppadoro

Lorenzo Coppadoro

Hematic treatments

PhD Candidate in Biomedical Eng.

Luca Giovanni Paroni

Luca Giovanni Paroni

Test optimization

Msc Biomedical Engineering

Msc in Global Health

Our partners

Divisione IIIª di Malattie Infettive dell'Università di Milano.

I medici e ricercatori della Divisione IIIª di Malattie Infettive dell’Università di Milano (Ospedale Sacco)
Prof. Spinello Antinori, Dott. Romualdo Grande

Hopital Saint Luc de Mbalmayo

Dott. Paul Tina (Direttore)
Joel Bombe (Responsabile del Laboratorio Diagnostico)

ONG COE

Rosa Scandella
(Presidente uscente)

Contact

Prof. Riccardo Bertacco

Department of Physics – Politecnico di Milano
Via Giuseppe Colombo 81, 20133 Milano (Italy)
tel. +39.02.2399.9663
info@tmekdiagnostics.com