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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 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 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 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.
XL DLEU/LAMP/12cen hybridized to bone marrow cells. Three interphases are shown of which one shows a normal signal pattern of 2 orange, 2 green, and 2 blue signals, one nucleus shows a hemizygous, and a third one a homozygous deletion of DLEU (orange).
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.
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.
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.
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.
We hope you had a chance to meet us.
