| ABOUT IPSOGEN | SCIENCE & TECHNOLOGY | PARTNERSHIPS | INVESTOR ROOM | MOLECULAR ASSAYS | NEWS & EVENTS |

The chromosomal translocation t(12;21)(p13;q22) constitutes the most common translocation in B lineage childhood Acute Lymphoblastic Leukemia (ALL), accounting for 25% of childhood ALL. It is not seen in childhood Acute Myeloid Leukemia (AML), and is very rare in adult ALL.
The t(12;21) fuses the helix loop helix domain of the TEL gene to the DNA binding and transactivation domains of AML1. TEL-AML1 forms dimers and may exert a dominant negative effect on TEL.
The fusion with TEL converts AML1 from an activator to a repressor of transcription.
t(12;21) positive patients retain a good prognosis and have a more delayed time of relapse.
A large prospective study demonstrated that TEL status is a significant predictor of outcome in childhood ALL, and should be assessed for risk stratification [Rubnitz JE et al. J. Clin. Oncol. (JCO) 2008]. Some studies have reported MRD results for TEL-AML1 positive patients relying on a qualitative or semi-quantitative evaluation of the transcript level. The first large prospective study using RQ-PCR for the quantification of TEL-AML1 transcripts in order to monitor residual disease clearly demonstrated that there is rapid MRD clearance in the vast majority of patients and that slower clearance of TEL-AML1 fusion gene transcripts predicted relapse. TEL-AML1 quantification by RQ-PCR was therefore proposed to suitably complement MRD analysis for the protocol required for risk stratification in childhood ALL [Fronkova E et al. Leukemia. 2005].
TEL-AML1 FusionQuant® technology uses Real-Time Quantitative RQ-PCR to quantify the expression level of specific TEL-AML1 fusion gene transcripts relative to ABL control gene.
Quantification of TEL-AML1 fusion gene transcripts has been standardized in the EAC (Europe Against Cancer) program [Gabert J et al. Leukemia. 2003, Beillard E et al. Leukemia. 2003], and IPSOGEN FusionQuant® kits use this validated technology to calibrate and normalize RQ-PCR results.
EAC Standardized RQ-PCR procedures
Calibrated and sensitive quantification of fusion gene transcript, normalized with ABL control gene (results in NCN)
Product manufactured under ISO 13485 certification ensuring optimal quality control and full traceability
Prospective analysis of TEL gene rearrangements in childhood acute lymphoblastic leukemia: a Children's Oncology Group study
J Clin Oncol. 2008
Authors: Rubnitz JE et al
TEL/AML 1 real-time quantitative reverse transcriptase PCR can complement minimal residual disease assessment in childhood ALL
Leukemia. 2005
Authors: Fronkova E et al.
Standardization and quality control studies of 'real-time' quantitative reverse transcriptase polymerase chain reaction of fusion gene transcripts for residual disease detection in leukemia - a Europe Against Cancer program.
Leukemia. 2003
Authors: Gabert J et al.
Evaluation of candidate control genes for diagnosis and residual disease detection in leukemic patients using 'real-time' quantitative reverse-transcriptase polymerase chain reaction (RQ-PCR) - a Europe against cancer program.
Leukemia. 2003
Authors: Beillard E et al.
