Asuragen, Inc. and Life Technologies Launch CE-Marked BCR/ABL1 Quant(TM) Leukemia Test in Europe
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.
About Asuragen
Asuragen is a fully integrated diagnostic development company and pharmaceutical services provider. The Company’s diagnostic product portfolio consists of the first-ever validated microRNA diagnostic assay for pancreatic cancer, quantitative RNA tests for leukemia gene translocations, and the Signature® Oncology and Genetic Testing products. Asuragen is empowered with a high level of scientific expertise and assay development capabilities, CLIA and GLP testing services, and an established cGMP manufacturing facility, which allow it to span the spectrum of discovery, testing, production and commercialization. For more information, visit www.asuragen.com.
Armored RNA Quant® is a registered trademark of Asuragen, Inc.
About Life Technologies
Life Technologies Corporation (NASDAQ: LIFE) is a global biotechnology tools company dedicated to improving the human condition. Our systems, consumables and services enable researchers to accelerate scientific exploration, driving to discoveries and developments that make life even better. Life Technologies customers do their work across the biological spectrum, working to advance personalized medicine, regenerative science, molecular diagnostics, agricultural and environmental research, and 21st century forensics. Life Technologies had sales of $3.3 billion in 2009, employs approximately 9,000 people, has a presence in approximately 160 countries, and possesses a rapidly growing intellectual property estate of approximately 3,900 patents and exclusive licenses. Life Technologies was created by the combination of Invitrogen Corporation and Applied Biosystems Inc., and manufactures both in-vitro diagnostic products and research use only-labeled products. For more information on how we are making a difference, please visit our website: http://www.lifetechnologies.com. Follow Life Technologies on Twitter @LIFECorporation and on Facebook.
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Contacts Asuragen, Inc. Rollie Carlson, 512-681-5200 President rcarlson@asuragen.com or Life Technologies Tim Ingersoll, 760-918-3883 Corporate Media Relations tim.ingersoll@lifetech.com