BCR-ABL Mbcr

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• About this biomarker
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CML belongs to the group of Myeloproliferative Neoplasms and is in > 90% of cases characterized by the presence of the Philadelphia (Ph) chromosome.

This chromosome is the product of t(9;22), a reciprocal translocation between the long arms of chromosomes 9 and 22. The corresponding fusion gene, BCR-ABL, is transcribed into an 8.5 KB mRNA, with 2 junction variants b2a2 (40% of cases) and b3a2 (55% of cases). The b2a3 and b3a3 transcripts represent less than 5% of cases.

The fusion gene encodes for a chimeric protein, p210, with elevated tyrosine kinase activity. A Ph Chromosome can also be detected in 35% of adult ALL patients. To date, the goal of CML therapy is to achieve 100% survival and Ph chromosome negativity.

Disease monitoring is therefore an essential tool to assess treatment response and detect early relapse for each individual patient. Under TKI therapy, patients typically progress from hematologic to cytogenetic and molecular remission, corresponding to decreasing numbers of leukemic cells and BCR-ABL transcripts.
Recommendations for CML disease monitoring have been recently updated to incorporate new clinical evidence from clinical trials as well as improved disease monitoring objectives and tools.

The most recent recommendations on response definition and monitoring of patients on imatinib come from the European LeukemiaNet group of experts [Baccarani M et al. Blood. 2006, Baccarani M et al. J. Clin. Oncol. (JCO) 2009].

From a technical standpoint, efforts have been made by international experts to harmonize BCR-ABL Mbcr testing and reporting [Branford S et al. Leukemia. 2006, Hughes T et al. Blood. 2006].

Additionally a reference panel has been recently validated by the WHO, and will allow for a simpler International standardization of BCR-ABL Mbcr quantification [White H et al. Blood. 2010].

BCR-ABL Mbcr IS-MMR kits utilize real-time quantitative PCR (RQ-PCR) to detect and quantify specific BCR-ABL fusion gene transcripts (p210) relative to ABL control gene expression in sample RNA.

IPSOGEN BCR-ABL Mbcr IS-MMR kits use single plasmid technology containing BCR-ABL and ABL targets to limit variability and include primers and probe sets designed according to the EAC standardization study [Gabert J et al. Leukemia. 2003, Beillard E et al. Leukemia. 2003].

In order to accurately measure molecular response, the kit also includes an ‘IS-MMR Calibrator’ allowing to convert NCN results to the International Scale and report MMR. Finally, a high positive control is provided to check for quality process of the experiment.

Why choose BCR-ABL Mbcr IS-MMR kits?

• BCR-ABL IS-NCN results converted to the International Scale

• IS-MMR Calibrator (RNA) included in the kit, for MMR status reporting

• Good sensitivity (LOD = 0.0069; LOB= 0.0022)

• 4 ABL dilutions for a more accurate quantification

• Single plasmid for BCR-ABL and ABL limiting variability

• Product manufactured under ISO 13485 certification ensuring optimal quality control and full traceability

  
  

Why choose BCR-ABL Mbcr FusionQuant® kits?

• EAC Standardized RQ-PCR procedures

• Compatibility with most RQ-PCR platforms

• Calibrated and sensitive quantification of fusion gene transcript, normalized with ABL (BCR or GUS) control gene (results in NCN)

• Product manufactured under ISO 13485 certification ensuring optimal quality control and full traceability