PORTEFEUILLE

Drug development is strongly accompanied by diagnostic tests to identify disease and to monitor the effectiveness of therapy. The number of blood cells in our body can provide important or even life-saving information about our state of health. For example, the number of cells in the blood can vary greatly in the case of a disease. By detecting such deviations, doctors can specifically rule out diseases and thus identify the cause of a change more quickly. Flow cytometry, currently the method of choice for the quantitative determination of blood cells, has numerous shortcomings, including relatively high costs, requires highly qualified personnel and complex and time-consuming sample handling and analysis.
The idea of the LifeCellAgglutination (LCA) diagnostic system is to simplify the diagnostic process for doctors, by developing and implementing a daily in-vitro diagnostic system for the quantification of human blood cells, and thereby improve the quality of life of the affected persons. The test is based on an antigen-antibody reaction between specific beads and the target cells, in this case the immune system relevant T cells from human whole blood. LCA serves as a fast, simple, sensitive/specific, low-cost system. No complex sample preparation is necessary, with only on drop of patients whole blood we can obtain the result in less than 10 minutes. In future tests the system can be modified in this way, that other cell populations or disease specific biomarkers can be measured and so creating a diagnostic platform. The LCA test system can be used not only in human diagnostics, but also in animal studies. Due to the advantages of the small amount of blood required, animal suffering is greatly reduced and the tests are performed under more controlled conditions. As a result, animal testing can be made more tolerable for rodents, the number of animals required can be reduced in the long term and the procedure is simplified for the user.

An analysis of the need shows that despite the advanced techniques used today in medical laboratories, such a fast, simple and cost-effective analytical alternative is profitable in many aspects.
The innovation of this test is that through many small but important criteria, a system can be created that can compete qualitatively and quantitatively with today's more expensive method. The advantage of this diagnostic method is that it is much cheaper than the method used today, not only because of the relatively low material costs, but also because of the acquisition costs, maintenance costs and support costs. In addition, it differs from other competitors in that it is significantly faster and does not require highly qualified personnel due to its simple implementation. This means that no lengthy and complex sample preparation times are required for this diagnostic test. The diagnostic test is developed as a so-called one-step test in which less than one drop of whole blood and a specific bead suspension are completely sufficient to quantitatively determine the living blood cells. Due to its versatility, the test can be designed in such a way that it will later serve as a so-called platform for various diseases.
Due to the fast reaction time, there is no waiting time for the results. Any changes in the blood count can thus be detected directly in order to carry out further specific examinations in order to make an exact diagnosis. This also includes that, depending on the change, various causes can be excluded right from the start. This not only simplifies further decisions by specialists but can also be vital for patients through early detection of diseases.

The principle and feasibility has been proven in various laboratory tests. In addition, successful development and optimisation steps of the test system, such as the principle of one-step analysis, reaction amplifiers, etc. have already been successfully tested. In further experiments the interaction with other cells or the beads alone (specificity) was clearly excluded. In addition to specificity, sensitivity was further increased by optimising various intermediate steps. The system was compared with the standard method flow cytometry and based on the results it offers a good alternative. First successful attempts to prove the platform possibility were successfully achieved with disease-specific proteins and thus offers the possibility to move towards POCT (Point-of-Care-Testing).
The project aroused the interest of the company aeChem. The company aeChem will now continue the project, create a functional device prototype and strive for the fastest possible market entry.

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