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Leukemia Fusion Gene One-Step Detection Kits


Product Name/Description
No. of Tests
Product Code
AML1-ETO One-Step Detection Kit
E2A-PBX1 One-Step Detection Kit
MLL-AF4 One-Step Detection Kit
PML-RARA bcr1, bcr2, bcr3 One-Step Detection Kit
TEL-AML1 One-Step Detection Kit
CBFB-MYH11 One-Step Detection Kit

Fusion Genes and Cancers

Many hematologic malignancies carry characteristic chromosomal translocations believed to play an important role in the pathogenesis of these tumors. Chromosomal translocations found in leukemias and lymphomas either fuse enhancer/promoter regions of one gene to another, causing aberrant expression, or by fusing a part of one gene to that of another, resulting in disruption of the normal function of the native genes involved in the translocation, or by gaining new oncogenic functions that promote proliferation and tumorigenesis.

Detection of fusion gene transcript expression to assess minimal residual disease (MRD) has been established as an independent prognostic indicator for treatment stratification and patient outcome in many leukemias. Molecular monitoring of patients enables clinicians to initiate therapy at the point of molecular relapse, which has been demonstrated to be beneficial in comparison to therapy adjustments at clinical relapse.

Assay Features

The One-Step Detection Kits provide reagents to detect and quantify the fusion gene transcripts listed below using total RNA isolated from blood or bone marrow. 

  • AML1-ETO: t(8;21)(q22;q22)
  • E2A-PBX1: t(1;19)(q23;p13)
  • MLL-AF4: t(4;11)(q21;q23), 4 variants: e10-e4, e10-e5, e11-e4, e11-e5
  • PML-RARA: t(15;17)(q22;q21), 3 variants: bcr1, bcr2, bcr3
  • TEL-AML1: t(12;21)(p13;q22)
  • CBFB-MYH11: Inv(16) (p13q22), 3 variants: type A, D, E

Some of the benefits of using this kit are: 

  • One-step cDNA synthesis and quantification – no need to perform separate cDNA synthesis and qPCR
  • Low contamination risk – no post-PCR product handling
  • Multiplexed - Reference and target genes assessed in the same reaction

Equipment and Materials

The One-Step Detection Kits require a real-time PCR instrument capable of detecting FAM™ and VIC® fluores. They do not include reagents and columns for isolation of total RNA from blood or bone marrow.

These kits include reagents required for cDNA synthesis and PCR amplification/detection, as well as validated reaction controls. Columns and reagents for RNA isolation are not included.


Intended Use

Available for research use only (RUO) and diagnostic (CE-IVD) purposes.