MetaSystems Probes has received IVDR certification for our XCyting FISH probes for prenatal aneusomy testing – the XA aneusomy probes.
Our Complete Set of XA Aneusomy Probes for Prenatal Testing Is IVDR Certified.
XL CDKN2C/
CKS1B
Enumeration Probe
- Order Number
- D-5099-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 011
- 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 large part of its portfolio, according to IVDR. For organizational reasons, we currently provide only the IVDD product.
XL CDKN2C/CKS1B consists of a green-labeled probe hybridizing to the CDKN2C (p18) gene region at 1p32.3 and an orange-labeled probe hybridizing to the CKS1B gene region at 1q21-22.
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.
Multiple myeloma (MM) is a plasma cell malignancy characterized by very complex cytogenetic and molecular genetic aberrations. Hyperdiploid karyotypes are characterized mainly by trisomies of chromosomes 3, 5, 7, 9, 11, 15, 19, and 21, non-hyperdiploid karytoypes typically have translocations involving the IGH locus at 14q32. The most frequent deletions are 13q, 17p and 1p32.
Deletions of chromosome 1p have been described in 7-15% of cases of myeloma with inconsistent clinical consequences. CDKN2C at 1p32.3 has been identified in myeloma cell lines as the potential target of the deletion. Gain of 1q is one of the most recurrent chromosomal aberrations in MM. Amplification and overexpression of the CKS1B gene in chromosome band 1q21 has been associated with an aggressive clinical course in MM.
Clinical Applications
- Multiple Myeloma and Plasma Cell Neoplasms (MM)
XL CDKN2C/CKS1B hybridized to lymphocytes. Three normal interphases are shown.
Normal Cell:
Two green (2G) and two orange (2O) signals.
Aberrant Cell (typical results):
Two green (2G) and three orange (3O) signals resulting from gain of one orange signal.
Aberrant Cell (typical results):
One green (1G) and two orange (2O) signals resulting from loss of one green signal.
- Hanamura et al (2006) Blood 108:1724-1732
- Leone et al (2008) Clin Cancer Res 14:6033-6041
- Jian et al (2016) Medicine 95:1-7
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.
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