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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 large part of its portfolio, according to IVDR. For organizational reasons, we currently provide only the IVDD product.
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 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.
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.
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:
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.
Aberrant Cell:
Three green (3G), three blue (3B) and two orange (2O) signals, indicating hyperdiploidy.
Certificate of Analysis (CoA)
or go to CoA DatabaseMetaSystems 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.
We hope you had a chance to meet us.
The IVDR is effective and our probes stay the same! A large segment of our portfolio is already IVDR-certified. Our priority is to give you a smooth transition into the IVDR era.
