Leukemia Test Launched in Europe

A clinically validated test that will aid clinicians in monitoring and treatment of individuals suffering with chronic myeloid leukemia (CML) has been launched in Europe.

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.

Asuragen, Inc. (Austin, TX, USA) and Life Technologies Corporation (Carlsbad, CA, USA) announced that they have achieved CE-marking of the BCR/ABL1 Quant test, Asuragen's current good manufacturing practice (cGMP) test. 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 polymerase chain reaction (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 (Ph+) chronic myeloid leukemia (CML) patients expressing b2a2, b3a2 or e1a2 fusion transcripts.

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.
"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,” remarked Rollie Carlson, president of Asuragen.
Asuragen is a fully integrated diagnostic development company and pharmaceutical services provider. The company's diagnostic product portfolio consists of a validated microRNA diagnostic assay for pancreatic cancer, quantitative RNA tests for leukemia gene translocations, and the Signature oncology and genetic testing products.

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.

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Asuragen, Inc.
Life Technologies Corporation