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 DLEU/LAMP
Deletion Probe
- Order Number
- D-5054-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 1313
- 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 DLEU/LAMP consists of an orange-labeled probe hybridizing to the DLEU1/MIR15A/MIR16-1 gene region at 13q14.2 including D13S319 and a green-labeled probe hybridizing to the LAMP1 gene region at 13q34.
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) are 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.
The most frequently deleted region in B-CLL is located in 13q14.3 distal to RB1. The minimal deleted region (MDR) is 350kb in size and includes the gene loci for the mi-RNAs 15 and 16. CLL with 13q deletion as the sole cytogenetic abnormality usually have a good prognosis.
Deletions of chromosomal region 13q14 have also been reported in a variety of human tumors, including other types of lymphoid tumors and myeloid leukemias, as well as prostate, head and neck, and non-small-cell lung cancers.
Clinical Applications
- Chronic Lymphocytic Leukemia (CLL)
- Multiple Myeloma and Plasma Cell Neoplasms (MM)
XL DLEU/LAMP hybridized to lymphocytes. One normal interphase and metaphase are shown.
Normal Cell:
Two green (2G) and two orange (2O) signals.
Aberrant Cell (typical results):
Two green (2G) and one orange (1O) signal resulting from loss of one orange signal.
Aberrant Cell (typical results):
One green (1G) and two orange (2O) signals, indicating a deletion of the terminal region of the long arm of chromosome 13.
Aberrant Cell (typical results):
One green (1G) and one orange (1O) signal, indicating deletions of both loci in 13q14 and 13qter.
- Doehner et al (2000) N Engl J Med 343:1910-1916
- Calin et al (2002) Proc Natl Acad Sci USA 99:15524-15529
- Gunn at al (2008) J Mol Diagn 10:442-451
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.
Greetings from Nijmegen, NL
We hope you had a chance to meet us.
