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 6q21/6q23/
6cen
Deletion Probe
- Order Number
- D-5088-100-TC
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 066
- 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 6q21/6q23/6cen consists of a green-labeled probe hybridizing to the SEC63 gene region at 6q21, an orange-labeled probe hybridizing to the MYB gene region at 6q23.3 and an aqua-labeled probe hybridizing to the centromere of chromosome 6.
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.
The prognosis and clinical course of chronic lymphocytic leukemia (CLL) is heterogeneous. Conventional banding techniques in CLL are hampered by the low mitotic index of the neoplastic cells. The introduction of interphase cytogenetics using fluorescent in situ hybridization (FISH) has greatly increased the sensitivity of cytogenetic analyses. With FISH, abnormalities can be detected in more than 80% of patients by using a 4-probe panel for the detection of trisomy 12q13-15 and deletions 13q14, 17p13, and 11q22-23. An additional 10% of patients can be shown to carry a 6q21 deletion, 14q32 translocation, and partial trisomy 3q or 8q.
Deletions involving the long arm of chromosome 6 (6q) are among the most common structural aberrations leading to a loss of chromosomal material in lymphoproliferative disorders and non-Hodgkin lymphoma (NHL). Two distinct regions, one at 6q21-22.1, the other at 6q23.3-25, have been found as minimal deleted regions in 6q- patients. A 6q deletion has been found in a variety of other human malignancies as well, including breast carcinoma, malignant melanoma, renal cell carcinoma, salivary gland adenocarcinoma, ovarian carcinoma, acute lymphoblastic leukemia, and nodal NHL.
Clinical Applications
- Acute Lymphoblastic Leukemia (ALL)
- Chronic Lymphocytic Leukemia (CLL)
- Non-Hodgkin Lymphomas (NHL)
XL 6q21/6q23/6cen 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):
Two blue (2B), one green (1G) and one orange (1O) signal resulting from the loss of one green and one orange signal.
Aberrant Cell (typical results):
Two blue (2B), two green (2G) and one orange (1O) signal resulting from the loss of one orange signal.
Aberrant Cell (typical results):
Two blue (2B), one green (1G) and two orange (2O) signals resulting from the loss of one green signal.
Aberrant Cell (typical results):
One green (1G), one orange (1O), and one blue (1B) signal indicating a monosomy 6.
- Stilgenbauer et al (1999) Leukemia 13:1331-1334
- Zhang et al (2000) Genes Chrom Canc 27:52-58
- Starostik et al (2000) Blood 95:1180-1187
Package Insert (EN)Package Insert (IT)Performance Data (English)Probes Catalog
Certificate of Analysis (CoA)
or go to CoA DatabaseIVDR 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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