Asuragen and Life Technologies obtained a CE-mark and have launched the BCR/ABL1 Quant™ Test in Europe. The in vitro diagnostic is intended to aid clinicians in the monitoring and treatment of individuals with chronic myeloid leukemia (CML).
Asuragen manufactures the test, which is exclusively distributed by Life Technologies. It runs on the company’s Applied Biosystems CE-marked 7500 Fast Dx Real-Time PCR Instrument™.
The BCR-ABL1 fusion gene arises from a specific chromosome translocation, known as the Philadelphia chromosome. The fusion transcripts are reportedly present in approximately 95% of CML cases. If present, the expression level of the fusion transcript or its ratio to a reference transcript may be used to monitor disease progress.
The BCR/ABL1 Quant Test monitors the BCR-ABL1 to ABL1 ratio by RT-qPCR on whole blood or bone marrow of Philadelphia chromosome positive CML patients expressing b2a2, b3a2, or e1a2 fusion transcripts. The test can be used to determine complete cytogenetic response, major molecular response, minimal residual disease, and relapse in CML patients.
“The BCR/ABL1 Quant Test provides several advantages over current methods by enabling multiplex detection of all targets in a single reaction and providing unmatched standardization through the use of our proprietary Armored RNA Quant® technology for external calibrators and process controls,” remarks Rollie Carlson, president of Asuragen.
Monitoring the level of BCR/ABL1 may be helpful for both prognosis and management of Gleevec®, Tasigna®, Sutent®, and Sprycell® kinase therapies in patients with leukemia disease, according to Asuragen and Life Technologies. The firms say that they have plans to pursue regulatory clearance for the BCR/ABL1 Quant test in the U.S.