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Asuragen announces launch of CE-IVD BCR-ABL assay

Asuragen announced the commercial launch of its CE-IVD Quantidex BCR-ABL IS CMR Kit for monitoring BCR-ABL1 transcript levels in patients with Chronic Myeloid Leukemia (CML).

Asuragen will introduce the assay at the European Hematology Association (EHA) 20th Annual Congress in Vienna, Austria, June 11-14th, 2015. The Quantidex™ BCR-ABL IS CMR Kit represents an improvement to existing tests by attaining a sensitivity of MR4.7 (0.002% IS) while also allowing direct reporting on the International Scale (IS).

BCR-ABL1 transcripts arise from a specific chromosomal translocation known as the Philadelphia chromosome that is the hallmark of CML. CML represents the first cancer type for which a personalized treatment was developed with the advent of Tyrosine Kinase Inhibitors (TKIs).

Quantitative BCR-ABL1 assays play an important role by monitoring the effectiveness of TKI therapy and detecting patient relapse early. However, the lack of clinical reporting on the IS across the globe has complicated patient monitoring and treatment.

Quantidex BCR-ABL IS CMR Kit addresses these challenges by providing unparalleled sensitivity (MR4.7), enabling detection of complete molecular response (CMR). The inclusion of IS reference materials for the creation of a standard curve allows the labs to report patient results directly on the IS without having to establish conversion factors.

These materials are based on Asuragen’s proprietary Armored RNA technology, which has been broadly incorporated into in vitro diagnostic kits. An RNA based standard curve combined with multiplexed assay design provides the customer a simplified yet robust assay set up.

"This product is a major step forward in providing labs with a BCR-ABL Kit with class leading sensitivity that keeps pace with the advances in TKI therapies and the need for IS standardization," said Matthew McManus, M.D., Ph.D., President and CEO of Asuragen Inc.

Asuragen will conduct a corporate workshop at the EHA congress on Friday, June 12th where one of its collaborators, Dr. Jean-Michel Cayuela from Hôpital Saint-Louis, will present his lab’s evaluation of this product. To attend this workshop and find out more about the product, please visit Asuragen at EHA booth #206.