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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
- IVDR
IVDR Certification
This probe is IVDR-certified in compliance with the Regulation (EU) 2017/746 for in vitro diagnostic medical devices (IVDR).
MetaSystems Probes has already certified a wide range of FISH probes, according to IVDR.
Please use the switch to change to the IVDD product.
IVDRIVDDDiscover all IVDR-certified productsDownload Instructions For Use (IFU)Until further notice, we will continue to provide IVDD products in various countries.
As part of our phased rollout, the IVDR-certified probes are now available in Australia, Austria, Bangladesh, Belgium, Croatia, Cyprus, Czech Republic, Estonia, France, Germany, Iceland, Italy, Jordan, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malta, Nepal, Netherlands, New Zealand, Oman, Palestine, Poland, Slovakia, Slovenia, South Africa, Switzerland, Ukraine, and United Arab Emirates with the list of countries continuously expanding.
Note: Our IVDR-certified XA probes are now available across all EU countries. For more details, please visit the individual product pages.
The XL 5p15/9q22/15q22 Hyperdiploidy enumeration probe is a qualitative, non-automated test for the detection of copy number variations of chromosomes 5, 9 and 15 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.
The XL 5p15/9q22/15q22 Hyperdiploidy enumeration probe 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.
XL 5p15/9q22/15q22 hybridized to lymphocytes. Two normal interphases are shown.
Normal Cell:
Two green (2G), two orange (2O), and two blue (2B) signals.
Aberrant Cell (typical results):
Three green (3G), two blue (2B) and three orange (3O) signals, indicating hyperdiploidy.
Aberrant Cell (typical results):
Three orange (3O), two green (2G) and three blue (3B) signals, indicating hyperdiploidy.
Aberrant Cell (typical results):
Three green (3G), three blue (3B) and two orange (2O) signals, indicating hyperdiploidy.
Tumour Genetics Symposium 2025
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European Cytogenetics Conference
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