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Standardisation and external quality controls are part of the routine in clinical biochemistry since years. International standards
and external quality control rounds are absolutely warranted for any new biological marker for its worldwide use into the
clinics. It is done for 40 years in biochemistry but such approach is still in it?s infancy for molecular biology tests Taking the
measurement of BCR ABL transcripts (M-BCR) as a model, we fi rst developed a standardisation eff ort and external quality
controls through the European Against Cancer (EAC) network then we developed freeze dried cells that can be sent worldwide
at room temperature. BCR ABL is present mainly in patients having a chronic myeloid leukemia (CML). Th is naturally deadly
disease has seen its prognostic revolutionized with the use of tyrosine kinase inhibitors targeting the BCR ABL protein. Now
there is an international consensus to adapt the treatment based on the dosage of BCR ABL gene expression by real time PCR.
We participated to the development of an international l standard based on freeze dried cells which has been validated by the
world Health Organization last year. During, the meeting will be reported our eff orts in this fi eld at the regional, national and
international levels and how biotech companies can participate to the eff ort of follow up improvement for health care patients.
Dr. Jean Gabert, Professor of Biochemistry and Molecular Biology, Faculty of Medicine, M?diterran?e University, Marseille (France).
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