Asuragen, Inc. and Life Technologies Corporation (NASDAQ: LIFE) announced today that they have achieved CE-marking and commercial launch in Europe of the BCR/ABL1 Quant™ Test, Asuragen's clinically validated and cGMP manufactured test intended to aid clinicians in the monitoring and treatment of individuals afflicted with chronic myeloid leukemia (CML). Asuragen manufacturers the monitoring test, which is exclusively distributed by Life Technologies and runs on the company's Applied Biosystems CE-marked 7500 Fast Dx Real-Time PCR Instrument™.
“Using genetic markers such as these to aid clinicians in monitoring disease progression is an important step in the evolution of personalized medicine.”
The CE-marked BCR/ABL1 Quant Test for leukemia progression is a quantitative in vitro diagnostic test to help doctors determine the most effective treatment options for CML. 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.
"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," said Rollie Carlson, President of Asuragen.
"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," said Kimberlee Caple, Head of Molecular Medicine Products for Life Technologies. "Using genetic markers such as these to aid clinicians in monitoring disease progression is an important step in the evolution of personalized medicine."
The BCR-ABL1 fusion gene arises from a specific chromosome translocation, known as the Philadelphia chromosome or t(9:22). The resulting BCR/ABL1 fusion transcripts are present in approximately 95% of CML. If present, the expression level of the fusion transcript or its ratio to a reference transcript may be used to monitor disease progress. 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 United States.
Asuragen, Inc. and Life Technologies Corporation