Labceutics has signed a agreement with Asuragen to conduct an international multi-center quality assurance study on the standardization of BCR-ABL1 quantitative measurements on the International Scale (IS).
Participating laboratories engaged in the continual improvement of their BCR-ABL1 testing performance via IS standardization have been recruited in five countries in Europe.
The study will evaluate the inter-laboratory variability of molecular monitoring results in chronic myeloid leukaemia (CML) patients treated with imatinib or second-generation tyrosine kinase inhibitors (TKIs).
As per the agreement, Labceutics will execute, analyze and report the study and Asuragen will provide analytical reference materials, which are calibrated to the primary international reference standards of the World Health Organization (WHO), the BCR-ABL1 ARQ IS Calibrator Panels.
The quality assurance scheme modeled study on existing External Quality Assessment (EQA) programs aims to measure the inter-laboratory variability of BCR-ABL1 RT-qPCR results using different standardization modalities.
Asuragen clinical development division director Dr Labourier said the firm's new study aims to provide more reliable and accurate test results, which helps to improve the management of patients with CML.
"The use of stable and commutable ARQ IS Calibrator Panels, based on our well-characterized and clinically validated Armored RNA technology, will give laboratories the ability to directly generate IS compatible results without the lengthy and complex process of sample exchange," Labourier added.
Labceutics managing director Maria Fe Paz said: "Demand for companion diagnostic testing is increasing rapidly across Europe and greater involvement of the Laboratory community is essential if we are to ensure physicians have the right test at the right time. This study is an example of laboratory collaboration on a pan European scale."
