XL CCND3/IGH DF

Translocation/Dual Fusion Probe

Order Number
D-5147-100-OG
Package Size
100 µl (10 Tests)
Labels
  
Chromosomes
614
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 CCND3/IGH DF dual-fusion probe is a qualitative, non-automated test for the detection of IGH::CCND3-rearrangements, t(6;14)(p21.1;q32.3) 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 multiple myeloma (MM). Hybridization is to be performed on methanol/acetic-acid fixed plasma cells.

Product Description

The XL CCND3/IGH DF dual-fusion probe consists of an orange-labeled probe hybridizing to the CCND3 gene and flanking regions at 6p21.1 and a green-labeled probe hybridizing to the IGH gene region at 14q32.3.

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Images

XL CCND3/IGH DF

XL CCND3/IGH DF is hybridized to bone marrow cells, one aberrant cell is shown. A translocation t(6;14)(p21;q32) has occurred generating a signal pattern of two colocalization/fusion signals, one green and one orange signal.

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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 greenorange colocalization/fusion signals (2GO) resulting from a reciprocal translocation between the respective loci.

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