Asuragen and Life Technologies BCR/ABL1 Quant Test

Asuragen and Life Technologies 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 leukaemia (CML). Asuragen manufactures 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.

The CE-marked BCR/ABL1 Quant Test for leukaemia 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 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 is claimed to provide several advantages over current methods by enabling multiplex detection of all targets in a single reaction and providing standardisation through the use of Armored RNA Quant technology for external calibrators and process controls.

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