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The BCR-ABL fusion gene is associated with formation of the Philadelphia chromosome (Ph) and is one of the most common genetic abnormalities detected in leukemia.
The Ph chromosome is found In more than 95% of Chronic Myeloid Leukemia (CML) cases and is the hallmark of this disease. In addition, in Acute Lymphoblastic Leukemia (ALL), Ph is detected in 20-40% of adult and 2-5% of childhood cases.

At the molecular level, the Ph chromosome or t(9;22) results in the juxtaposition of the 5' part of the BCR gene (chromosome 22) to the 3' part of the ABL gene (chromosome 9).

In the vast majority of patients, the breakpoints in the BCR gene are clustered within three well defined regions:

• Minor breakpoint cluster region (mbcr): corresponding to BCR gene (e1) juxtaposed to these condexon of the ABL gene exon (a2).
• Major breakpoint cluster region (Mbcr): corresponding to BCR gene exon (b3) or (b2) juxtaposed to these condexon of the ABL gene exon (a2) and the fusion transcripts (b3-a2 and b2-a2, respectively).
• Micro breakpoint cluster region (µbcr): very rare.

Therapy of Ph+ patients has been revolutionized by the introduction of tyrosine kinase inhibitors. Since the frequency of cytogenetic response is now very high, it is necessary to measure the level of BCR-ABL transcripts to determine MRD.

See relevant publications

Ipsogen FusionQuant® kits are unique molecular kits providing standardization and accurate quantification of fusion gene transcripts in leukemia.

FusionQuant® kit key points

• Sensitive and quantitative measurement of the fusion transcript
• Determination of the expression level of the fusion transcript relative to the ABL, GUS or BCR control genes
• Facilities and QMS compliant with ISO 13485 : 2003
• Multi-instrument compatibility
• Ready to use pre-diluted solutions
• Reduced risk of contamination
• Validated standards for the specific fusion and control gene
• EAC Standardized RQ-PCR procedures

Ipsogen BCR-ABL Mbcr / ABL FusionQuant® Kits are unique molecular kits providing standardization and accurate quantification of fusion gene transcripts in leukemia.

BCR-ABL Mbcr / ABL FusionQuant® Kit key points

Clinical advantages

• Sensitive follow-up of Minimal Residual Disease in patients under Imatinib (Gleevec®)
• Standardized technology validated by a multicentric study (EAC network)
• Ready-to-Use CE marked kits for In Vitro Diagnostic
• Clinical significance demonstrated and validated by leading institutions

Laboratory advantages

• Use peripheral blood specimen instead of bone marrow
• Quick test less than 3-hour turn-around time
• Reduced risk of contamination
• Sensitive quantitative measurement of BCR-ABL Mbcr
• Available: Cell Lines (Positive, Low and Negative controls for BCR-ABL Mbcr) used as Qualitative Control of total RNA extraction, reverse transcription and amplification steps for the RQ-PCR analysis

Description & performances

• 24 to 30 patient samples in duplicate
• Results in normalized copy numbers (NCN)
• Facilities and QMS compliant with ISO 13485 : 2003
• Multiplatform compatibility
• Sensitivity in Normalized Copy Number: 0.084
  
  
  

Ipsogen BCR-ABL Mbcr Dx FusionQuant® Kit is a unique RQ-PCR assay to help in the evaluation of major and complete cytogenetic responses and for minimal residual disease follow-up in CML patients.

BCR-ABL Mbcr Dx FusionQuant® Kit key points

• Complete ready-to-use kit with enzymes for RT and RQ-PCR steps
• Accurate and sensitive quantification of BCR-ABL Mbcr b3a2 and b2a2 transcripts
• Analytical sensitivity of the test: 0.084 BCR-ABL Normalized Copy Number (NCN) (NCN = BCR-ABL_CN / ABL_CN x 100)
• Less than 5-hour turn-around time
• Facilities and QMS compliant with ISO 13485 : 2003
• Reduced risk of contamination
• Controls allowing monitoring of RT and RQ-PCR steps
• Technology validated in the EAC standardization study

Main Products
Biomarker	Product	Indication(s)	Content	Product description	Instructions for use	Material Safety Data Sheet	Product reference	Add to basket
BCR-ABL Mbcr Dx	FusionQuant® + RT & Q-PCR Enzyme Kit	Monitoring	24 samples in duplicate				FQPP-10-DX-CE
BCR-ABL Mbcr RQ	Calibration Kit +  RQ Kit	Monitoring	24 samples in duplicate				FQPP-10-RQ-CE
BCR-ABL Mbcr / ABL	BCR-ABL Mbcr / ABL FusionQuant®Kit	Monitoring	24-30 samples in duplicate				FQPP-10-CE
BCR-ABL mbcr / ABL	FusionQuant®Kit	Monitoring	24-30 samples in duplicate				FQPP-09-CE
BCR-ABL Mbcr / ABL	FusionQuant® Mega Kit	Monitoring	52-64 samples in duplicate				FQPP-10M-CE
Associated Products
Biomarker	Product	Indication(s)	Content	Product description	Instructions for use	Material Safety Data Sheet	Product reference	Add to basket
RT complete set	Reverse Transcription Dx Kit	Monitoring	33 reactions				RT-01-CE
BCR-ABL Mbcr Control Kit	Control Cell Lines (RUO product)	Monitoring	1 reaction				CLCK-01
BCR-ABL mbcr Control Kit	Control Cell Lines (RUO product)	Monitoring	1 reaction				CLCK-02
High BCR-ABL Mbcr Positive Control	Control Cell Lines (RUO product)	Monitoring	1 reaction				PCCL-01
High BCR-ABL mbcr	Control Cell Lines (RUO product)	Monitoring	1 reaction				PCCL-02
Low BCR-ABL Mbcr Positive Control	Control Cell Lines (RUO product)	Monitoring	1 reaction				PCCL-03
Low BCR-ABL mbcr Positive Control	Control Cell Lines (RUO product)	Monitoring	1 reaction				PCCL-04
Negative BCR-ABL Mbcr & mbcr	Control Cell Lines (RUO product)	Monitoring	1 reaction				PCCL-05