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XL 5p15/9q22/15q22 Hyperdiploidy
Enumeration Probe
- Order Number
- D-5095-100-TC
- Package Size
- 100 µl (10 Tests)
- Regulatory Status
- IVDD
IVDR Certification
This probe is IVDR-certified in compliance with the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
MetaSystems Probes has already certified a wide range of FISH probes, according to IVDR.
This product remains IVDD-certified until further notice.
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XL 5p15/9q22/15q22 Hyperdiploidy consists of a green-labeled probe hybridizing to a region at 5p15.2-15.3, an aqua-labeled probe hybridizing to a region at 9q22.3-31 and an orange-labeled probe hybridizing to the SMAD6 gene region at 15q22.3.
Probe maps for selected products have been updated. These updates ensure a consistent presentation of all gaps larger than 10 kb including adjustments to markers, genes, and related elements. This update does not affect the device characteristics or product composition. Please refer to the list to find out which products now include updated probe maps.
Probe map details are based on UCSC Genome Browser GRCh37/hg19, with map components not to scale.
In multiple myeloma (MM) pathogenesis, hyperdiploidy and non-hyperdiploidy are recognized as two major cytogenetic pathways. The hyperdiploid group is characterized by gains of the odd chromosomes 3, 5, 7, 9, 11, 15, 19, and 21. Hyperdiploidy has been internationally defined and requires trisomy for at least 2 of the 3 chromosomes 5, 9, and 15.
Patients with hyperdiploid MM, which can be observed in 50-60% of MM patients, tend to have a better prognosis than those with a non-hyperdiploid subtype.
Clinical Applications
- MM
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Normal Cell:
Two green (2G), two orange (2O), and two blue (2B) signals.

Aberrant Cell:
Three green (3G), two blue (2B) and three orange (3O) signals, indicating hyperdiploidy.

Aberrant Cell:
Three orange (3O), two green (2G) and three blue (3B) signals, indicating hyperdiploidy.
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Aberrant Cell:
Three green (3G), three blue (3B) and two orange (2O) signals, indicating hyperdiploidy.
- Wuilleme et al (2005) Leukemia 19:275-278
- Kumar et al (2009) Mayo Clin Proc 84:1095-1110
- Bochtler et al (2011) Blood 117:3809-3815
Certificate of Analysis (CoA)
or go to CoA Database