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XL DLEU/LAMP/12cen
Deletion/Enumeration Probe
- Order Number
- D-5055-100-TC
- Package Size
- 100 µl (10 Tests)
- 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 wide range of FISH probes, according to IVDR.
This product remains IVDD-certified until further notice.
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XL DLEU/LAMP/12cen consists of a green-labeled probe hybridizing to the centromere of chromosome 12, an orange-labeled probe hybridizing to the DLEU1/MIR15A/MIR16-1 gene region at 13q14.2 including D13S319 and an aqua-labeled probe hybridizing to the LAMP1 gene region at 13q34.
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.
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 350 kb 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)

Normal Cell:
Two Blue (2B), two green (2G) and two orange (2O) signals.

Aberrant Cell:
Two blue (2B) two orange (2O) and three green (3G) signals resulting from a gain of the green labeled chromosome.
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Aberrant Cell:
Two blue (2B), two green (2G) and one orange (1O) signal resulting from loss of one orange signal.

Aberrant Cell:
Two green (2G), one orange (1O), and one blue (1B) signal.
- Doehner et al (2000) N Engl J Med 34:1910-1916
- DeWald et al (2003) Brit J Haem 121:287-295
- Nelson at al (2007) Am J Clin Pathol 128:323-332
Certificate of Analysis (CoA)
or go to CoA Database