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A New State-Of-The-Art Diagnostic Test

Prohost Biotech - Wednesday, July 14, 2010
The Biotechnology Revolution: A New State-Of-The-Art Diagnostic Test

Genomics are changing the way medicine is being practiced, bringing to the labs state-of-the-art diagnostic tests that do much more than ruling in, or out diseases. The new laboratory tests enable physicians to determine the most effective treatment options for their patients’ diseases, to monitor the disease progression and install the treatment at the right time.  This is no dream any longer, but reality. The latest news about achievements in this domain comes from Life Technologies (LIFE) and Asuragen, which announced yesterday they have achieved CE-marking and commercial launch in Europe of the BCR/ABL1 Quant™ Test that  enables clinicians to monitor and treat patients afflicted with chronic myeloid leukemia (CML).

Asuragen's clinically validated and cGMP manufactured the BCR/ABL1 Quant™ Test, which is  distributed by Life Technologies (LIFE) and runs on its Applied Biosystems’ CE-marked 7500 Fast Dx Real-Time PCR Instrument™. The test for leukemia progression is a quantitative in vitro diagnostic test. It helps 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 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.

To read the press release and about the firms go to:    

Asuragen and Life Technologies have plans to pursue future regulatory clearance for a BCR/ABL1 Quant test in the United States. 

See Also: Illumina (ILMN), Sequenom (SQNM), Clinical Data (CLDA), Compugen (CGEN)
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