Asuragen announces publication on standardization of BCR-ABL1 testing on the international scale
AUSTIN, TX – April 23, 2013 – Asuragen, Inc. announced today that the results of an international, multi-center validation study on its ARQ IS Calibrator Panels* have been published online and will appear in Clinical Chemistry. The study, performed in collaboration with clinical laboratories in Australia, Canada, Brazil, Germany, Italy, Korea, Spain, the UK and the USA, shows that secondary reference panels calibrated to the primary standards of the World Health Organization (WHO) can facilitate the standardization of BCR-ABL1 RT-qPCR results on the international scale (IS).
Monitoring of residual disease in chronic myeloid leukemia (CML) patients undergoing tyrosine kinase inhibitor therapy is performed in clinical laboratories worldwide using a variety of RT-qPCR technologies, platforms, assay designs and calibration materials. The IS was established to standardize the reporting of BCR-ABL1 quantitative measurements on a single unit and harmonize the definition of clinically-validated treatment response criteria in CML. The ARQ IS Calibrator Panels are commutable secondary standards based on Asuragen’s Armored RNA® technology that provide a means for testing laboratories to align the results of their molecular assays to the IS reference values of the 1st WHO International Genetic Reference Panel for quantitation of BCR-ABL1 translocation by RT-qPCR. “The data generated in our study confirms the utility and performance of the Armored RNA calibrators, anchored to the WHO primary standards, for alignment to the IS and facilitation of inter-laboratory comparative studies, both of which are essential for global standardization of BCR-ABL1 monitoring and optimization of new therapeutic approaches” said Dr Nick Cross, Professor of Human Genetics at the University of Southampton School of Medicine, UK.
The paper includes data supporting the stability, reproducibility and compatibility of the synthetic calibrators with various RT-qPCR methods commonly used worldwide in both IS and non-IS standardized laboratories. It also demonstrates the utility of the 4-level panel design to assess the linearity, analytical sensitivity and imprecision of local RT-qPCR methods and achieve precise analytical calibration to the IS across a clinically representative range of BCR-ABL1 expression levels. These unique features are expected to minimize the requirement for clinical laboratories to perform lengthy and costly inter-laboratory sample exchanges and, ultimately, to reduce the potential drift of methods already standardized on the IS. “With the commercial availability and adoption of these secondary reference materials, our CML community here in Brazil has now the opportunity to more easily and economically achieve nationwide standardization to the IS” added Dr. Israel Bendit, co-author of the paper and Professor of Hematology and Oncology at the University of Sao Paulo Medical School, Brazil.
For additional background and educational information on the IS and inter-laboratory standardization of BCR-ABL1 RT-qPCR results, visitwww.whereareyouontheis.com.
About AsuragenAsuragen is a molecular diagnostics company with a pioneering position in miRNA using genomics to drive better patient management through best-in-class clinical testing solutions. The Company uses a breadth of technologies and talent to discover, develop and commercialize diagnostic products and clinical testing services with efficiency and flexibility both internally and for our companion diagnostic partners. Today, Asuragen’s products, services and technologies drive countless patient management decisions across oncology, genetic disease and other molecular testing modalities. In the future, we envision the Company’s development of miRNA-based clinical diagnostics will help transform medicine by improving clinical outcomes and health economics. For more information, visit www.asuragen.com.
*For Research Use Only. Not for use in diagnostic procedures.