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Asuragen BCR-ABL Assay Receives CE Mark

NEW YORK (GenomeWeb) – Asuragen today announced its Quantidex BCR-ABL IS CMR Kit has received the CE-IVD mark. 

The firm is launching the kit for monitoring BCR-ABL1 transcript levels in chronic myeloid leukemia patients this week. According to Asuragen, the product improves upon other tests by attaining a sensitivity of MR4.7 while it allows direct reporting on the International Scale. Additionally, the assay enables detection of complete molecular response. 

BCR-ABL1 transcripts arise from a chromosomal translocation called the Philadelphia chromosome that is associated with CML. While tyrosine kinase inhibitors represent a personalized approach to treating CML, and quantitative BRC-ABL1 testing can be crucial in monitoring the effectiveness of TKI therapy, the lack of reporting on the IS has complicated patient monitoring and treatment, Asuragen said. 

Its assay "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," Asuragen President and CEO Matthew McManus said in a statement.