The IVDMDQ08 Project

A short summary

The aim of the project is to develop a unique predictive in vitro diagnostic (IVD) test system that is able to predict multidrug transporter related resistance to the standard first-line therapies in malignant and autoimmune diseases, allowing personalized medication for the patients.

The principle of this kit to be developed is based on Solvo's patented Calcein-assay, which is a flow cytometric test system. In addition, a user-friendly laboratory analyzer will be developed by the 77 Elektronika Kft., which can automate the analytical steps and save labour time in the laboratories.

In 2008, members of the consortium have got a NKTH-NTP grant of 408 million HUF. The project is planned for 40 months and requires ca. 50 Man years of R&D work. The key to successful development and clinical trials is the consortium including highly competent industrial partners (SOLVO, 77 Elektronika, T-sejt Orvosdiagnosztika) and 3 universities (SZTE Szent-Györgyi Albert Klinikai Központ, DEOEC, PTE-OEKK); this consortium has all the necessary professional competences which provide the completion of the strict regulation regarding IVD devices during development, manufacturing, the clinical evaluation of its efficiency and the authorization. The scientific publications and evidences emerging during the project play an important role in the marketing of the products.

Scientific background: Tumours are often characterized by resistance to a broad spectrum of structurally unrelated cytotoxic drugs (i.e. multidrug-resistance - MDR). This phenomenon usually results from the expression of ATP-binding cassette (ABC) transporters, such as the ABCB1 (MDR1 or P-gp), ABCC1 (MRP1), and ABCG2 (MXR or BCRP), which are known to function as drug efflux pumps causing drug resistance by actively extruding multiple anticancer drugs with expenses of ATP. Concordant clinical data show that incidence of multidrug resistance (MDR) in the previously untreated cases is approximately 40%, making it the most frequent type of resistance.

Measurement of the activity of these membrane transporters in the target cells could help predicting the resistance of these cells to particular cytotoxic agents. Thereby those patients could be selected, who will respond more effectively to drug therapy and decrease the frequency of adverse effects, improving the standards of oncological attendance. Using predictive tests expenses of inefficient treatments could be saved just like the adverse effects for the patient. By choosing alternative therapy chances of recovery could be improved.