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The PML-RARa fusion gene transcripts, which are the molecular result of the t(15;17)(q22;q21) translocation, are associated with the majority of APL cases (> 90%), a distinct AML subset with M3 cytomorphology. APL accounts for 10-15% of all AML cases.
The balanced reciprocal translocation t(15;17) leads to the fusion of the promyelocytic leukemia (PML) gene to the retinoic acid receptor alpha (RARa) to generate the PML-RARa fusion protein, a transcriptional repressor. Its expression is associated with impaired myeloid differentiation.

RARa breakpoints always occur in intron 2. Depending on the location of breakpoints within the PML site, intron 6, exon 6 and intron 3, the respective PML-RARa transcript subtypes referred to as long (L or bcr1), variant (V or bcr2) and short (S or bcr3), may be formed. They represent 55%, 5% and 40% of the cases respectively.

The analysis of the prognostic value of a well established standardized RQ-PCR protocol (EAC Program) in APL patients during different phases of treatment has indicated that this approach is a robust alternative for assessing MRD and that a relapse-risk stratification can be established based on PML-RARa normalized copy number.

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 PML-RARA bcr1 FusionQuant® Kits are unique molecular kits providing standardization and accurate quantification of fusion gene transcripts in leukemia.

PML-RARA bcr1 FusionQuant® Kit key points

Clinical advantages

• Sensitive follow up of Minimal Residual Disease in patients under ATRA
• Standardized technology validated by a multicentric study (EAC network)
• Ready-to Use CE marked kit (PML-RARA bcr1) for IVD
• Relapse-risk stratification can be established based on PML-RARa level of expression
• PML-RARA monitoring by FusionQuant® Kits splits patients into three groups:
  • high risk of relapse
  • intermediate risk
  • low risk of relapse
• Treatment type and intensity are modulated accordingly during follow-up

Laboratory advantages

• Use peripheral blood specimen instead of bone marrow
• Gold standard technology adopted by leader institutions
• Rapid test less than 3 hours turn-around time

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 comparable to the BCR-ABL FusionQuant® Kit

Main Products
Biomarker	Product	Indication(s)	Content	Product description	Instructions for use	Material Safety Data Sheet	Product reference	Add to basket
PML-RARa bcr1	PML-RARA bcr1 FusionQuant®Kit	Monitoring	24-30 samples in duplicate				FQPP-05
PML-RARa bcr2	FusionQuant®Kit	Monitoring	24-30 samples in duplicate				FQPP-06
PML-RARa bcr3	FusionQuant®Kit	Monitoring	24-30 samples in duplicate				FQPP-07
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 Kit	Monitoring	33 reactions				RT-01
PML-RARa bcr1 Control kit	Control Cell Lines (RUO product)	Monitoring	1 reaction				CLCK-03
High PML-RARa bcr1 Control	Control Cell Lines (RUO product)	Monitoring	1 reaction				PCCL-06
Low PML-RARa bcr1 Control	Control Cell Lines (RUO product)	Monitoring	1 reaction				PCCL-07
Negative Control for PML-RARa	Control Cell Lines (RUO product)	Monitoring	1 reaction				PCCL-08
PML-RARA bcr1 Fusion Gene Standard	FusionQuant® Standards	Monitoring	4 reactions in duplicate				FGRS-05
PML-RARA bcr2 Fusion Gene Standard	FusionQuant® Standards	Monitoring	4 reactions in duplicate				FGRS-06
PML-RARA bcr3 Fusion Gene Standard	FusionQuant® Standards	Monitoring	4 reactions in duplicate				FGRS-07
ABL Control Gene	FusionQuant® CG Standards		4 reactions in duplicate				CGRS-01
B2M Control Gene	FusionQuant® CG Standards		4 reactions in duplicate				CGRS-02
GUS Control Gene	FusionQuant® CG Standards		4 reactions in duplicate				CGRS-03
TBP Control Gene	FusionQuant® CG Standards		4 reactions in duplicate				CGRS-04
BCR Control Gene	FusionQuant® CG Standards		4 reactions in duplicate				CGRS-05