Break Apart Probe

Order Number
Package Size
100 µl (10 Tests)
Regulatory Status

IVDR Certification

MetaSystems Probes has already certified a large part of its portfolio, according to IVDR. For organizational reasons, we currently provide only the IVDD product.

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Product Description


XL CCND1 consists of an orange-labeled probe hybridizing proximal to the MYEOV gene region at 11q13.3 and a green-labeled probe hybridizing to CCND1 and distal to the CCND1 gene region at 11q13.3.

Probe maps are created in accordance with the intended purpose of the product. Solid colored bars do not necessarily indicate that the probe fully covers the indicated genomic region. Therefore, caution is advised when interpreting results generated through off-label use. Probe map details based on UCSC Genome Browser GRCh37/hg19. Map components not to scale. Further information is available on request.

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Clinical Details

The t(11;14)(q13;q32) chromosomal translocation is the hallmark of mantle cell lymphoma (MCL) and is found in approximately 30% of multiple myeloma (MM) tumors with a 14q32 translocation. Variant translocations can fuse CCND1 with other genes, such as IGK or IGL.

Clinical Applications

  • Multiple Myeloma and Plasma Cell Neoplasms (MM)
  • Non-Hodgkin Lymphomas (NHL)
  • Chronic Lymphocytic Leukemia (CLL)
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XL CCND1 hybridized to lymphocytes. One normal metaphase and two normal interphases are shown.

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Expected Patterns

Expected Pattern 1

Normal Cell:
Two green-orange (2GO) fusion signals representing the two normal CCND1 loci.

Expected Pattern 2

Aberrant Cell (typical results):
One green (1G), one orange (1O), and one green-orange (1GO) fusion signal, indicating a chromosome break in the CCND1 locus.

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  • Vandraager et al (1997) Blood 89:349-350
  • Fonseca et al (2002) Blood 99:3735-3741
  • Wlodarska et al (2004) Leukemia 18:1705-1710



IVDR Certification

MetaSystems Probes has received IVDR certification for our initial 26 fluorescence in situ hybridization (FISH) probes from the notified body, BSI. Achieving this milestone was not without its challenges, and we are delighted to have accomplished IVDR certification for this probe set at an early stage.

IVDR Certification