Asuragen Inc, Austin, Tex, has launched its Quantidex BCR-ABL IS CMR kit for monitoring BCR-ABL1 transcript levels in patients with chronic myeloid leukemia (CML).
According to the company, the CE-marked kit represents an improvement over existing tests by attaining a molecular response (MR) sensitivity of 4.7 using the standardized international scale (IS).
BCR-ABL1 transcripts arise from a specific chromosomal translocation known as the Philadelphia chromosome, which is the hallmark of CML. CML represents the first type of cancer for which a personalized treatment was developed, with the advent of tyrosine kinase inhibitors (TKIs). Quantitative BCR-ABL1 assays play an important role in patient care 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. Asuragen’s kit addresses these challenges by providing sensitivity that enables detection of complete molecular response. The inclusion of IS reference materials for the creation of a standard curve enables 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 aim to provide the customer with a simplified yet robust assay setup.
“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,” says Matthew McManus, MD, PhD, president and chief executive of Asuragen.
For more information, visit Asuragen.
