Asuragen and Life Technologies have received CE-mark for BCR/ABL1 Quant Test, a clinically validated cGMP manufactured test intended to aid clinicians in the monitoring and treatment of individuals affected with chronic myeloid leukemia (CML), in Europe.
Asuragen manufactures the monitoring test, which is exclusively distributed by Life Technologies and runs on the Applied Biosystems CE-marked 7500 Fast Dx Real-Time PCR Instrument.
The test monitors the BCR-ABL1 to ABL1 ratio by reverse transcription quantitative polymerase chain reaction (RT-qPCR) on whole blood or bone marrow of diagnosed Philadelphia chromosome positive chronic myeloid leukemia (CML) patients expressing b2a2, b3a2 or e1a2 fusion transcripts.
The test is intended as an aid in the assessment of complete cytogenetic response (CCyR), major molecular response (MMR), minimal residual disease and relapse in CML patients.
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. Asuragen and Life Technologies have plans to pursue future regulatory clearance for a BCR/ABL1 Quant test in the US.
Rollie Carlson, president of Asuragen, said: “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.”
Kimberlee Caple, head of molecular medicine products at Life Technologies, said: “Life Technologies is committed to providing versatile molecular diagnostic platforms which simplify the development of sensitive and specific diagnostic assays, and have the potential to impact the way patients are treated. Using genetic markers such as these to aid clinicians in monitoring disease progression is an important step in the evolution of personalized medicine.”