Asuragen and Labceutics Report Results from Pan European Quality Assurance-Modeled Study on Standardization of BCR-ABL1 Monitoring for CML Patients
Austin, Texas and Belfast, United Kingdom – September 4, 2014 – Asuragen, Inc., a molecular diagnostics company using genomics to drive better patient management, and Labceutics, the leading global personalized medicine laboratory network, announced today the publication of the results from the first international, multi-center quality assurance study on the standardization of BCR-ABL1 quantitative measurements on the International Scale (IS). The double-blinded study assessed the variability of BCR-ABL1 testing by quantitative reverse transcription PCR (RT-qPCR) across 15 clinical laboratories performing routine monitoring of chronic myeloid leukemia (CML) patients treated with tyrosine kinase inhibitors (TKIs) in five European countries. The data demonstrate that the use of secondary IS reference materials anchored to the primary IS reference standards of the World Health Organization, the ARQ ISTM Calibrator Panels, can improve the precision and accuracy of BCR-ABL1 testing. The study results were initially reported at the 15th International Conference on CML organized by the European School of Haematology and the International Chronic Myeloid Leukemia Foundation in Estoril, Portugal, and were published by the College of American Pathologists in Archives of Pathology & Laboratory Medicine.
“Optimal management of CML patients requires the precise measurement of BCR-ABL1 expression relative to IS-standardized treatment response criteria that have been validated in extensive clinical trials,” said Professor Michael Griffiths, Consultant Clinical Scientist & Director of the West Midlands Regional Genetics Laboratory in Birmingham, United Kingdom,and first author of the study report. “During our evaluation, we observed that the ARQ IS Calibrator Panels enabled standardization of RT-qPCR data with an IS accuracy similar to the current method based on the exchange of clinical samples between laboratories, but with a 3-fold increase in inter-laboratory precision.”
Dr. Jean-Michel Cayuela, Head of Molecular Hematology Laboratory at Hôpital Saint Louisin Paris, France, and study co-author, added “The availability of these validated secondary reference materials will facilitate global diffusion of the IS and, ultimately, will contribute to improve the quality of molecular monitoring data that are critical to optimize treatment outcome of CML patients.”
The ARQ IS Calibrator Panels consist of precisely quantified and nuclease resistant RNA molecules based on Asuragen’s proprietary Armored RNA Quant® technology. The commutability of these panels and their utility as secondary IS reference materials have previously been validated in an independent international collaborative study published in 2013 by the American Association of Clinical Chemistry. “The development and manufacturing of high quality RT-qPCR reagents and IS standards for BCR-ABL1 testing illustrate our commitment to provide clinical laboratories with robust and validated solutions that positively impact patient care worldwide,” commented Matthew McManus, M.D., Ph.D., President and CEO of Asuragen. Dr. Maria Fe Paz, President of Labceutics and study co-author, added, “This work is a perfect example of productive collaboration between the laboratory community and the pharmaceutical and diagnostic industries to provide physicians with optimal tools for the delivery of personalized medicine.”
Asuragen is a molecular diagnostics company using genomics to drive better patient management in oncology and genetic diseases through world leading clinical testing solutions. The company uses a breadth of technologies and scientific talent to discover, develop and commercialize diagnostic products and clinical testing services with efficiency and flexibility both internally and with its 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 molecular-based clinical diagnostics will help transform medicine by improving clinical outcomes and health economics. For more information, visit www.asuragen.com.
Labceutics partners with leading laboratories globally to provide pharmaceutical and diagnostic companies with the only “one-stop” personalized medicine laboratory partner. Currently Labceutics enables seamless introduction of companion diagnostic testing to over 200 leading institutions and laboratories and ensures a focus on delivering high quality laboratory services to physicians. www.labceutics.com.
Armored RNA Quant® is a registered trademark of Asuragen.
SVP Commercial Operations, Asuragen
+1 512 681 5200
Dr. Maria Fe Paz
+34 670 551 276