Standardisation of molecular diagnostics for CML

SUMMARY Real Time PCR enables an adequate molecular monitoring of the chronic myelogenous leukemia (CML) without which in the case of this disease it is impossible to thoroughly evaluate therapy response especially when modern target inhibitory molecules involved. Unfortunately, discrepancy and methodological deviations of the results obtained by different researches hinder a proper involvement of different labs and clinics into international research protocols and makes it impossible to compare the data obtained. In this paper we discuss the different approaches to standardize Real Time PCR technique and stress the significance of the international effort to incorporate International Scale (IS) into BCR / ABL gene expression monitoring of CML as well as a great importance of the regular sample exchange between participating labs and necessity of the calculation of individual conversion factor (CF) for each lab involved. Nowadays CF is the only way to turn the data collected from different labs into the universal and comprehensive IS scale. The Lab for Genetic Engineering of Research Center for Hematology (Moscow) is the only one in Russia that successfully fulfilled all necessary steps of standardization procedure and obtained a position of the national reference lab for Russia. We report here the preliminary results of the Russian program of BCR / ABL Real Time PCR standardization that has been started under our supervision.