XL t(6;9) DEK/NUP214

Translocation/Dual Fusion Probe

Order Number
D-5097-100-OG
Package Size
100 µl (10 Tests)
Labels
  
Chromosomes
69
Regulatory Status
IVDR

IVDR Certification

This probe is IVDR-certified in compliance with the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). For organizational reasons, we currently provide only the IVDD product.

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Intended Purpose

The XL t(6;9) DEK/NUP214 dual-fusion probe is a qualitative, non-automated test for the detection of DEK::NUP214-rearrangements, t(6;9)(q22.3;q34.1) by fluorescence in situ hybridization (FISH). The product is intended as a diagnostic aid and assists in disease monitoring. The test population consists of patients with confirmed or suspected acute myeloid leukemia (AML). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood.

Product Description

The XL t(6;9) DEK/NUP214 dual-fusion probe consists of a green-labeled probe hybridizing to the DEK gene region at 6p22.3 and an orange-labeled probe hybridizing to the NUP214 gene region at 9q34.1.

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Images

XL t(6;9) DEK/NUP214

XL t(6;9) DEK/NUP214 hybridized to lymphocytes. One normal metaphase is shown.

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Expected Patterns

Expected Pattern 1

Normal Cell:
Two green (2G) and two orange (2O) signals.

Expected Pattern 2

Aberrant Cell (typical results):
One green (1G), one orange (1O), and two green-orange colocalization/fusion signals (2GO) resulting from a reciprocal translocation between the respective loci.

Expected Pattern 3

Aberrant Cell (typical results):
One green-orange colocalization/fusion signal (1GO), one separate green (1G) and orange (1O) signal each resulting from a loss of one colocalization/fusion signal.

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